Validation Scientist Resume Samples

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K Steuber

Kelley

Steuber

546 Cyril Groves

San Francisco

+1 (555) 328 8721

546 Cyril Groves

San Francisco

Phone

p +1 (555) 328 8721

Experience Experience

Phoenix, AZ

Validation Scientist

Phoenix, AZ

Leffler, Roob and Reynolds

Phoenix, AZ

Validation Scientist

Provide support and recommendations for FDA-level analytical method development and method validations
Analyze test results, draft validation/engineering reports and make technical recommendations
Applies the highest quality standard in all areas of responsibility
Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’s
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training
Develop self and maintain knowledge in software test engineering field at all times
Experimental design development and execution, including technical writing of Method Validation Plans and Reports

Boston, MA

Process Validation Group Scientist

Boston, MA

Hartmann, Hyatt and Pagac

Boston, MA

Process Validation Group Scientist

Support the sales group by working with customers in the development of new test methods and specifications for custom products
Assist manufacturing groups in troubleshooting problems
Assist manufacturing group with process optimization
Test method development and validation involving LC-MS
Conduct experiments in the development/validation of robust, cost effective manufacturing protocols and test methods
Effectively manage activities associated with multiple, concurrent, and complex projects to deliver results in a timely manner
Maintain an audit-ready work environment and detailed laboratory notebooks

present

Phoenix, AZ

Senior Validation Scientist

Phoenix, AZ

Batz, Ruecker and Walker

present

Phoenix, AZ

Senior Validation Scientist

present

Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures
Under the supervision of the Team Leader-Services Engineering, Global Services, assist in the development and validation of Waters Qualification Products
Develop and execute sterilization and cleaning characterization / validation protocols
Complete complex or novel assignments requiring development of new and/or improved process validation techniques and procedures
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints
Develop process validation policies and procedures that affect multiple organizational units
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis

Education Education

Bachelor’s Degree in Chemistry

Ball State University

Bachelor’s Degree in Chemistry

Skills Skills

Strong ELISA knowledge
Ability to work independently and translate technical / quality/ compliance theory into practical application
Proven ability in technical writing skills including writing SOPs
Working knowledge of common central laboratory instruments and operating systems
Ability to handle multiple priorities
Working knowledge of production processes and equipment
Ability to independently perform root cause analysis for method investigations
Demonstrated ability to lead projects and teams
Good written and oral communication skills
Technical writing ability in an FDA regulated industry

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15 Validation Scientist resume templates

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Validation Scientist Resume Examples & Samples

Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Performs and maintains training as appropriate
Performs routine cGMP testing of validation samples for client using appropriate methods including HPLC, CE, and compendial methods
Participates in method assessments as applicable and appropriate to meet client’s needs
Executes method validations with minimal guidance from management and in accordance with approved protocols and client SOPs, ensuring technical and regulatory compliance
Communicates promptly with management any method or instrumentation problems, and assists in troubleshooting as appropriate
Communicates effectively with management and other staff members in a positive manner
Relevant GMP validation experience and experience with proteins
Strong focus on quality, teamwork, and productivity
Ability to prioritize and coordinate simultaneous projects with varying deadlines
Excellent communication (oral and written), listening skills, as well as interpersonal skills required. attention to detail
Ability to learn new techniques, perform multiple tasks simultaneously, attention to detail, keep accurate records, follow instructions, and comply with company policies
Bachelor’s degree in biochemistry, chemistry, analytical chemistry, chemical engineering, or other related degree concentration, with 3 or more years of relevant industrial experience

Assoc Validation Scientist Resume Examples & Samples

Perform late stage development, qualification and validation of inspections methods for consumable products
Learn and understand the applicable technology and engage in technical discussions
Provide expert technical input with respect to method validation requirements and related Regulatory requirements

Validation Scientist Resume Examples & Samples

B.S. in Chemistry, Biology, Biochemistry, Immunology or related science field and 3+ years new test validation or R&D experience in a CRO, clinical lab or regulated laboratory environment (not academia)
Candidates with Medical Laboratory Scientist (MLS) accreditation or other ASCP certifications are highly preferred
Candidates with experience in regulated environments are highly preferred
Follow analytical method validation best practices guidelines including the Clinical & Laboratory Standards Institute (CLSI) and CAP/CLIA regulatory requirements
Working knowledge of common central laboratory instruments and operating systems
Strong ELISA knowledge
Proven ability in technical writing skills including writing SOPs
Additional clinical chemistry laboratory sub-specialties of interest include: molecular virology, microbiology, and flow cytometry

Validation Scientist Resume Examples & Samples

Develop and execute validation protocols for inspection methods used at all levels of consumable manufacturing
Analyze test results, draft validation/engineering reports and make technical recommendations
Participate in project management meetings as Validation representative determining validation requirements, as needed
Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO

Computerised Systems Validation Scientist Resume Examples & Samples

Generation of validation documents including plans, protocols, reports and exceptions liaising with other functions as necessary
Participating in supplier assurance assessments and reviewing vendor supplied documentation
Co-ordinating with Customers on Process Validation / Automation activities
Reviewing Process and Analytical Development reports and other supporting documentation relating to the new Products, or changes to existing products and assessing their suitability for Validation
Write or amend Batch Manufacturing Records as required when directly related to Validation activities for existing products
Researching and writing Validation Strategies and Periodic Process Validation Reviews and other documents as required
Participate in validation system reviews to ensure validation practices are in compliance with most up to date regulatory requirements
Provide technical / validation guidance in assessment of process deviation with respect to equipment performance and impact on product quality
Knowledge of pharmaceutical validation requirements
Experience of preparing documentation for reports, protocols and SOPs
Advanced numeracy / literacy (experience of statistical packages)

Process Validation Group Scientist Resume Examples & Samples

Conduct experiments in the development/validation of robust, cost effective manufacturing protocols and test methods
Draft specification sheets for new raw materials
Effectively manage activities associated with multiple, concurrent, and complex projects to deliver results in a timely manner
Maintain an audit-ready work environment and detailed laboratory notebooks
Execute experimental plans utilizing applicable statistical tools
Coordinate projects with vendors and contract laboratories
Support the sales group by working with customers in the development of new test methods and specifications for custom products
Assist manufacturing groups in troubleshooting problems
B.S. degree in Chemistry, Biochemistry, Cell Biology or related field, with 5+ years experience; or an M.S. degree with 2+ years of experience
Ability to learn and apply continuous improvement principles, Design of Experiments (DOE), and Measurement System Analysis (MSA)
Ability to interpret and summarize complex experimental results
Ability to manage projects and adhere to timelines while working independently
Experience with cell culture and antibody conjugation/purification
Experience with ELISA, flow cytometry and Western blot analysis

Validation Scientist Resume Examples & Samples

Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing
Position Qualifications and Experience Requirements
BS in Engineering, Physical or Biological Science with 3+ years validation related experience or Associates Degree with 6+ years specific validation experience. Proven demonstration to perform in the role may also be considered

Senior Validation Scientist Resume Examples & Samples

Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures
Develop validation engineering policies and procedures that affect multiple organizational units
Develop sterilization and cleaning characterization / validation strategies
Develop and execute sterilization and cleaning characterization / validation protocols
Develop and approve sterilization and cleaning characterization / validation protocols
Support Non Conformance and Change Control assessments
Support New Product Introduction "NPI" business cases development and deployment
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis
Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise
Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints
Prompt and regular attendance to the workplace
Be flexible to support extended hour, non-standard shifts and manage changes
Applies extensive technical validation expertise, and has full knowledge of other related disciplines
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives
Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters
Essential to the completion of broad programs and projects
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization
Leads efforts of group of peers directly supervises staff or project resources
Guides the successful completion of major programs and may function in a project leadership role
May be expected to directly supervise staff or project resources
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body
Represents the organization as the technical expert to endorse the organization’s validation programs and practices
Handle multiple projects at one time
Education discipline/background in Life Sciences and/or Engineering
Knowledge of sterilization and cleaning processes / equipment
Exposure to key systems such as Trackwise, EDMQ and EPICS
Advanced scientific analysis, troubleshooting and laboratory work skills
Fully bilingual (English/Spanish)
In-depth knowledge of validation processes and requirements
Interacts effectively with variety of communication and working styles
Demonstrated Skills in the following areas

Senior Scientist Verification & Validation Resume Examples & Samples

Contributes to the commercialization of new VetLab reagent products through participation on new product development teams
Collaborates with assay development team in the development of product calibration processes, and implements the processes in operations
Leads studies to verify and/or validate new product designs or design changes to new and on-market assay products and instruments
Ensures the proper deployment of V&V tools and industry recognized best practices in the design and execution of V&V studies
Leads investigations into customer facing questions and/or complaints associated with the analytical performance of on-market products
Discussion and presentation of results to small teams as well as larger cross-functional audiences
May mentor or supervise scientific associates or scientists
Background in Biochemistry or Chemistry or Chemical Engineering preferred
Expertise in verification and validation principles and concepts as they relate to commercial clinical chemistry products
Experience with assay calibration methods that ensure reproducible product accuracy throughout the product life-cycle desired but not required
Complex problem-solving skills and ability to apply a broad range of tools to critically evaluate, interpret and summarize data with ability to propose next steps
Excellent project planning and management skills
Strong customer focus and concern for quality
Excellent verbal, technical writing, presentation communication skills
Experience with ISO / FDA-QSR a plus
Experience with JMP statistical software a plus

Process Validation Group Scientist Resume Examples & Samples

Qualification and verification of Liquid Chromatography Mass Spectrometry (LC-MS) systems
Test method development and validation involving LC-MS
Draft documents including instrument SOPs, test method validation plans/reports and material qualification plans/reports
Assist manufacturing group with process optimization
B.S. degree in Chemistry, Biochemistry, Cell Biology or related field, with 3+ years LC-MS experience; or an M.S. degree with 2+ years of LC-MS experience

Validation Scientist Resume Examples & Samples

Investigates and troubleshoots validation problems for equipment and/or performance processes and conducts equipment qualification activities
Conducts analyses of testing results and process anomalies
Work independently and as a team member to plan, write, and execute test cases according to company Quality Management System, FDA regulations, and ISO standards
Facilitate the identification, analysis, and documentation of product functional anomalies
Design new test procedures for new features and functionality
Develop self and maintain knowledge in software test engineering field at all times
Works in a team environment under close supervision using clearly defined procedures
Ability to carry out general biochemical laboratory procedures including handling of human blood/serum samples and reagents for testing purposes

Method Transfer & Validation Scientist Resume Examples & Samples

Attend Prioritization meetings to support assay transfer, co-validation, qualification and batch production release/stability testing for demonstration, engineering, clinical trial, process validation and/or commercial manufacturing in a GMP environment as needed
Responsible for becoming proficient in a breadth of methodologies including but not limited to compendial test methods, raw material test methods, HPLC, electrophoresis, spectrophotometric, compendial test methods, and ELISA
Responsible for working effectively with electronic, as well as paper based systems including LIMS and data acquisition systems including but not limited to Empower
Execute test methods, tabulate data and provide data interpretation
Troubleshooting in support of investigative testing may be required
Assay transfer experience
Experience executing test methods in the biotech or pharmaceutical industry

Instrument Validation Scientist Resume Examples & Samples

Primary responsibilities of this position are
In-depth knowledge, understanding, and experience performing bioassay and/or cell based assays
Formal training and experience with analytical instrumentation (e.g. PCR, KF, plate readers, or automated liquid handlers)
MS in Molecular Biology or related discipline with eight years relevant experience in biotech industry; or BS with a minimum of ten years relevant experience

Process Validation Scientist Resume Examples & Samples

Solid dosage background, preferably generic
Process pre-validation and validation batches
Dry blending, compression and powder encapsulation
Wet granulation, drying ( tray/fluid bed)
Wurster coating or film coating experience

Scientist, Validation Resume Examples & Samples

Work with product marketing and scientists to generate sound requirements and to develop, execute and document all verification and validation activities
Familiarity with applications in all areas including Clinical, Environmental and Food Safety, Pharma//Biopharma, and Proteomics of Thermo Fisher Scientific`s TSQ instruments
Ability to plan and execute activities with a strong sense of urgency to deliver results

Validation Scientist Resume Examples & Samples

Excellent written and oral communication skills, including report writing
Proficiency with PCs and software such as Access; Excel; Word; PowerPoint, MiniTab
Ability to handle multiple priorities
Ability to work independently and translate technical / quality/ compliance theory into practical application
Technical writing ability in an FDA regulated industry
Demonstrated ability to lead projects and teams
Working knowledge of production processes and equipment
Analytical and problem solving skills
Thorough understanding of regulatory standards including GMPs
Working knowledge of instrumentation and data collection

Principal Validation Scientist Resume Examples & Samples

Excellent knowledge technical tools
Proficient in utilization of special tools/equipment, and specialized facilities e.g., aseptic processing areas
Strong knowledge of relevant SOP, GLP, and GMP regulations and policies

Validation Scientist Resume Examples & Samples

Experimental design development and execution, including technical writing of Method Validation Plans and Reports
Routine analytical support for developmental batches / reagents / stability
Assay, validation and related substances & method development
Timely completion of documentation and online entries into document control
Adhere to CLIA/CAP/GLP systems and processes in the lab; maintain a high quality and accuracy of work
Provide support and recommendations for FDA-level analytical method development and method validations

Senior Validation Scientist Resume Examples & Samples

Under the supervision of the Team Leader-Services Engineering, Global Services, assist in the development and validation of Waters Qualification Products
Perform compliance product validation for LC-MS instrumentation/systems
Interface with multiple stakeholders throughout Sustaining, Global Service Support, Product Development and Quality Assurance
Assemble LC-MS systems, including required software, to perform compliance product validation. Perform critical review of process and procedures as well as documentation
Ensure critical deadlines are met for qualification validation efforts
Plan, schedule and perform qualification product validation
Ensure that lab equipment is maintained and fully functional
Ensure that lab supplies are maintained and available Generate validation reports specific to system level qualification products
Execute and document the qualification and validation of LC-MS systems equipment, processes, and manufactured components to meet the requirements defined by our Quality Manual and our Customers' requirements
Ensure that applicable regulations, guidelines and company procedures are followed and applied during all stages of validation activities
Create qualification and validation deliverables, such as validation project plans, risk assessments, validation (e.g., IQ, OQ) protocols, commissioning plans, and commissioning and validation summary reports
Work with cross-functional teams to evaluate and set milestones to ensure validation projects are on schedule and meet quality compliance requirements
Identify and coordinate activities required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plans. Support risk assessment and control activities
No degree and seven (7) years of experience troubleshooting hardware and chemical issues related to mass spectrometers or, a Bachelor's degree in Chemistry or related scientific field (willing to accept foreign education equivalent) and five (5) years of experience as stated above or, a Master’s degree in one of the enumerated fields and three (3) years of experience as noted above
Demonstrated Expertise repairing and maintaining tandem quadrupole and Quadrupole-TOF mass spectrometers
Demonstrated Expertise repairing and maintaining SFC systems
Demonstrated Expertise utilizing software platforms to merge LC and high performance MS data as well as chromatography data software for scientific laboratory-based organizations and instrument control
Demonstrated Expertise repairing, maintaining, and operating UPLC technology systems
Demonstrated Expertise utilizing a compliant-ready data repository and a flexible analytical electronic laboratory notebook to capture and archive data
Position requires up to 20% domestic/international travel

Validation Scientist Resume Examples & Samples

Lead and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g.CAPA/DN/MDNs etc)
Lead and close process related deviations and reports
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training
Protocol/report authoring/execution
Ensure highest Quality, Compliance and Safety standards
Participate and comply with the MSD Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant
Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives
Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’s
Author Change controls and MIDAS documents as appropriate
Level 8 honours degree in a science or engineering discipline
At least 1 years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment
Excellent leadership skills with a demonstrated ability to motivate and coach others to achieve results
Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables
Openness to and ability to affect change
Demonstrated ability to be self driven with respect to implementing identified improvement initiatives

Scientist Virus Validation Resume Examples & Samples

Independently design, perform, analyze, evaluate, document and present laboratory studies according to scientific rationale and regulatory / internal guidelines and quality standards
Summarize, present and discuss respective studies, concepts and methods within the company, externally and during regulatory audits
Closely cooperate with technical staff in the lab. Provide technical/functional guidance and training within the lab
Actively collaborate in internal project teams. These teams may be global and include different functions
Support technical innovation by providing own ideas and approaches and identify and implement advancements in relevant technology, methods and equipment
Contribute data / documentation for regulatory submissions and support preparation and examination of patent applications/patents
Live, maintain and support improvement of relevant quality (GLP / GMP) and health, environmental & safety standards in the lab
Prepare and review test protocols/ SOPs / data summaries / assessments / reports / publications / presentations in English / German
Support development of new templates / documentation concepts and the choice of appropriate lab equipment and material, prepare user requirements and design / perform equipment qualification
Advanced degree in a relevant field of Life Sciences e.g. bachelor / master / PhD in Biotechnology / Biochemistry / Biology / Bio Engineering or corresponding qualification based on work experience in a relevant field
2-5 years working experience in the field of virology / virus validation / process development preferably in an industry environment
High proficiency in English
Advanced knowledge / experience in virology and in several relevant fields e.g. process development / DOE, pathogen safety, recombinant and protein technologies, cell culture, validation, GXP requirements
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
Excellent communication, planning, organizational and analytical skills
Ability to work successfully in a matrix organization structure
Strong language skills in English and German (oral and written) is of Advantage

Senior Validation Scientist Resume Examples & Samples

Complete complex or novel assignments requiring development of new and/or improved process validation techniques and procedures
Develop process validation policies and procedures that affect multiple organizational units
Employ advanced process validation techniques and/or modifications of advanced techniques within area of process validation expertise
Apply knowledge of process validation principles and practices outside of area of expertise to broad variety of assignments in related fields
Work with project managers to complete the process validation responsibilities of technology transfer and commercial operation projects within schedule, budget and quality constraints
Applies extensive technical process validation expertise, and has full knowledge of other related disciplines
Represents the organization as the prime process validation technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations
Represents the organization as the technical expert to endorse the organization’s process validation program and practices
Advanced validation knowledge (process, cleaning)
Experience in process/cleaning validation execution
Experience in validation protocol and reports generation and execution
Understanding of the biologics drug substance manufacturing processes (cell culture/fermentation, chromatography, filtration and separation processes)
Experience in evaluation for validation deviations impacts
In-depth knowledge and experience of process validation processes and requirements
Ability to handle multiple projects at one time
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Skills in the following areas

Biodefense Reg Lab Assay Validation Scientist Resume Examples & Samples

This position for an Analytical Method Validation Scientist is part of USAMRIID’s expansion of its capabilities to perform Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) to facilitate approval of biomedical products by FDA
Knowledge and experience shall support performing the following specific laboratory tasks for 4 – 8 projects of varying scope per year
The candidate will carry out optimization, qualification and validation of bioassays (e.g., cell-based, immunological assays or nucleic acid amplification) for biological characterization and testing of biopharmaceutical products, such as DNA vaccines and recombinant proteins
The candidate will take a lead role in the development, optimization, and validation of a wide variety of bioassays, in accordance with pharmaceutical industry standards and best practices, as well as FDA regulatory expectations for use in GLP-compliant studies
The candidate must be familiar with SOP, GLP and GMP requirements and contribute to the creation and review of documents such as development reports, SOPs, validation protocols/reports, and CMC regulatory filings (e.g., IND, IMPD, BLA, etc.)
The candidate must be able to work in a team structure and interface with different research and development departments
The contract employee will be expected to work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed). Enrollment in the Biological Personnel Reliability Program (BPRP) for handling select agents is required and must be maintained conference annually
Knowledge of FDA guidelines (animal rule, new drug regulation, etc)
GLP experience
Animal protocol experience
Protocol validation experience
Draft new SOPs and revise existing ones
Electronic archiving of study data
Hands-on laboratory experience, preferably as a study coordinator or director

Validation Scientist Resume Examples & Samples

An additional 2+ years experience required for higher levels
Experience with Flow and Molecular Assays
Working knowledge of common central laboratory instruments and operating systems is highly preferred
Additional clinical chemistry laboratory subspecialties of interest include: molecular virology, microbiology, and flow cytometry

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