Validation Job Description
Validation
provides technical knowledge and feedback to the SATA, SAS, and PCIe specifications.
Validation Duties & Responsibilities
To write an effective validation job description, begin by listing detailed duties, responsibilities and expectations. We have included validation job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure that GMP principles are applied to guarantee quality of supplied products
Ensure that GMP principles are applied to guarantee quality of product in optimum supply period
Produce and maintain appropriate and comprehensive validation policy and procedures
Document and maintain in good order all relevant validation sections of Device Development History File and DMR as directed by local management
Lead re-validation process as required due to engineering change, deviation analysis or upgrade in systems and materiel
Manage and provide direction for change control for the site
Be responsible for the use of statistical QA methods to the highest industry standards for all validations locally and to provide input for global sites
Ensure compliance with all Documented Quality system, as per SEP 180 FDA QSR's and ISO 13485/9001 requirements during day to day and assigned audit/CAPA activities
Monitor and establish key metrics to monitor the effectiveness of the validation process
To operate within the company's standard operating procedures where applicable, and review, maintain and create appropriate procedures
Validation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation
List any licenses or certifications required by the position: ASQ, ISTQB, DFSS, ISO, PMP, CQE, WHCK, ISEB, CTQ, FDA
Education for Validation
Typically a job would require a certain level of education.
Employers hiring for the validation job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Education, Computer Science, Electrical Engineering, Life Sciences, Chemistry, Chemical Engineering, Associates
Skills for Validation
Desired skills for validation include:
Python
Statistics
GMP
SATA
C
SQL
CGMP
Server and SoC platform architectures is desired
Memory
PCIe
Desired experience for validation includes:
Carry out problem analysis as required, and define through negotiation effective corrective actions
Knowledge in computer hardware architecture
Very good analytical thinking, problem solving and communication skills
Bachelor's Degree in Science, Engineering or related subject
A Hons Degree in Engineering or a related Life Science
Degree level qualification in Science/Engineering or Equivalent
Validation Examples
1
Validation Job Description
Job Description Example
Our company is growing rapidly and is hiring for a validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation
- The incumbent will be called upon to assist with the development and introduction of new ISEE service delivery models aimed at improving the overall level of compliance and efficiency
- Participate in the periodic review during product life cycle (APRs, reviews ) to deepen process performance understanding, highlight trends and suggest improvements to increase process capability
- Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ)
- Write, execute, review, or approve Change Controls
- Write, review, or approve Periodic Reviews
- Interact frequently with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations
- Issues, reviews, or approves document change requests
- Perform QA inspections including, but not limited to, Internal Audits and Supplier Audits
- Participate as needed to support Client and Regulatory audits
- Cross functional Metrology and QA Representative for Equipment/Software Validations
Qualifications for validation
- Experience in aspects of QA, validation and ISO 13485
- Quality Engineering experience preferable but not essential
- Extensive understanding and application of validation principles, concepts, practices, and standards
- Bachelor's or Master's degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8-10 years relevant experience in the biotechnology and/or pharmaceutical industry
- Fluent in English and in local language
- Seven years experience in manufacturing/ manufacturing science and technology/technical development/Quality
2
Validation Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of validation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation
- Represent the department during audits, meetings, and teleconferences regarding process validation issues with the FDA
- Participate as a validation expert in product transfer process
- Participate in Technical Risk Assessments (TRA’s) and relevant production trials as a support to technical team
- Perform self inspection audits for validation department
- Participate in the gap analysis on relevant QMS policies, identify gaps between in-place and in-use and develop CAPAs to address identified gaps
- Provide PPR expert in Giza site with required data about products and process equipment machines validation status
- Participate in the assessment of relevant quality alerts and determine applicability to site in coordination with quality compliance team
- Lead validation life cycle implementation for manufacturing equipment, facilities, control systems, HVAC, purified water, and utility systems
- Design and create CSV protocols based on 21 CFR Part 11 requirements
- Apply problem solving systems/techniques to systems issues
Qualifications for validation
- This position requires knowledge of GLP regulations in an R&D Environment
- Either direct knowledge of IDEA and SAP or the ability to quickly learn the use of these systems is required
- A familiarity of how Engineering Systems
- The incumbent must be able to corroboratively work with teams and individuals to fulfill the responsibilities described above
- Accuracy in quality of work and timeliness are an essential requirement of this position given the regulatory compliance requirements of the position
- Generate and realise project plans concerning specific validation/qualification projects or activities
3
Validation Job Description
Job Description Example
Our company is searching for experienced candidates for the position of validation. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation
- Perform, report Validation Review for validated systems according to planned schedule and assess with Validation Review panel members the system validity and maintenance status
- Track department metrics and ensure 100% compliance with targets
- Perform L1 audits on validation sections as an effective member of L1 audit team
- Participate in the gap analysis on relevant QMS policies, identify gaps between in-place and in-use and develop CAPA plans to address identified gaps
- Provide PPR Expert in Cairo Site with required data about process equipment machines’ status to facilitate the process of product data processing and analysis
- Work with the technical entities in Lean validation and Validation Life-Cycle simplification
- Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes
- Manage and coordinate the Validation / Documentation processes within the plant including Change Requests for validated systems, Commissioning Documents, Engineering Studies, IQ/OQ/PQ validation protocols, and Master Validation Pan for the site
- Develop and execute validation packages, conclusions, explanatory memos, deviation reports and other documentation needed in support of the plant Validation processes
- Manage and coordinate the yearly equipment / line revalidation efforts required by Abbott policy
Qualifications for validation
- Experience in leading and executing process and cleaning validation
- Minimum three (3) years of relevant metrology, validation, or process engineering experience
- Seven (7) years of administrative, customer service and/or relevant business experience preferably in regulated GxP environment
- Demonstrated high degree of accuracy, problem-solving and problem resolution attention to detail
- Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required
- University degree in Pharmaceutical Chemistry and Technologies, biochemistry, biology, chemistry, industrial or chemical engineering or equivalent
4
Validation Job Description
Job Description Example
Our innovative and growing company is looking for a validation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for validation
- Manage and coordinate the Validation Review Board process
- Track and report on key Validation metrics for input into the weekly and monthly management review processes
- Conduct periodic reviews of the Validation Documentation / Process to verify that the program is on track for meeting goals, objectives and milestones
- Provide backup support to the plant’s Calibration coordination process including calibration alerts and review of calibration records
- Develop, implement and maintain process validation procedures to current regulatory, industry, and corporate standards
- Conduct CSV activities as required to support local systems, represent the site on Global CSV projects as required
- Collect environmental, water, and air samples as required
- Assist in client audits, visits, and inquiries
- Review and approve pre- and post-execution change controls as they impact the validated state
- Evaluate and drive continuous improvement in the validation program
Qualifications for validation
- Experience of at least 2 years in validation departments of Pharmaceutical industries
- Knowledge of international validation guidelines
- Good knowledge of English (written and oral)
- Must be an effective communicator, able to effectively lead teams and interface well with the organization
- Bachelor’s Degree in Engineering, Chemistry, Biology or related field*
- Minimum of five years related experience and/or training or equivalent combination of education and experience
5
Validation Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation
- Maintains SQO validation databases up to date
- Maintains test equipment calibration events up to date and manages test equipment repairs
- Enters and tracks SQO validation equipment, supplies, and materials purchase orders
- Manages training requirements for the group
- Owner of SOP, transversal CAPA / transversal risk & issues, involvement in validation deviation and voice of the site regarding process validation
- First line of training for process validation
- Fronter during corporate and regulatory inspections for process validation related topics
- Implement and maintain tools to support, train and simplify process validation
- Support discipline engineer of BeEM in the project for subject linked to process validation
- Technical writing of control note books in standard client procedure format
Qualifications for validation
- Experience in generation and execution of qualification protocols for validation of pharmaceutical processes, systems and equipment, programming and operation of data loggers, ,”Kaye Digistrips”, and basic computer skills
- Collect requirement from team members, to perform their duties, trainings, Silicons, HW/SW tools, Debuggers, boards, , and work with local and cross-site management to provide solutions
- Bachelors of Pharmacy
- Minimum of 2 years of experience in quality department
- Ability to work under stress and to manage conflicting priorities
- Bachelor’s degree in an Engineering/Scientific discipline