Senior Engineer, Validation Job Description

Senior Engineer, Validation Job Description

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Senior engineer, validation provides interpretation and Guidance on Regulations, Corporate, Divisional and Site Local Procedures as they relate to Computer Systems/Software Validation activities.

Senior Engineer, Validation Duties & Responsibilities

To write an effective senior engineer, validation job description, begin by listing detailed duties, responsibilities and expectations. We have included senior engineer, validation job description templates that you can modify and use.

Sample responsibilities for this position include:

This position will be responsible for leading equipment, utilities, automation and cleaning validation activities and projects for Shire
Support tech transfer activities as required and provide technical assessments on change controls, deviations, and investigations
Periodic travel may be required for business meetings with vendors/contractors and to stay current with professional development
Determine type and methods of tests and execution of test cases to derive the best results
Perform cleaning validation and qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification)
As needed manage and provide directions to contract personnel performing cleaning validation and facility/equipment/utility qualification
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort
Support the development of validation master plans, validation plans, SOPs, risk assessments, user requirements, and validation protocols for new facility/equipment/utility, and process/equipment modifications
Support validation periodic reviews, requalification, and revalidation
As needed prepare and update validation policies, master plans, and SOPs

Senior Engineer, Validation Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Senior Engineer, Validation

List any licenses or certifications required by the position: ISTQB, NPI, NTI, ASQ, CQE, NI, CMQOE, ISO, CSEP, ASEP

Education for Senior Engineer, Validation

Typically a job would require a certain level of education.

Employers hiring for the senior engineer, 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, Computer Science, Science, Electrical Engineering, Technical, Computer Engineering, Chemistry, Education, Life Sciences, Manufacturing

Skills for Senior Engineer, Validation

Desired skills for senior engineer, validation include:

Quality Concepts
Ability to provide Interpretation and Guidance on Regulations
Corporate
Divisional and Site Local procedures as they relate to validation activities
Address decoding
Aseptic processing highly desired
CGMP regulations and latest validation guidelines
Drivers
Firmware
I/O subsystems

Desired experience for senior engineer, validation includes:

A min of a Level 8 NFQ Science or Engineering Degree level is essential
Excellent verbal and written communication skills are essential for this role
Working knowledge of functional and non-functional software testing, the software test life cycle, and various test design methodologies (function, performance, stress, load, risk-based, scenario)
Working knowledge of multiple scripting languages (Perl, Python)
Software testing training (SQE, ISTQB)
Minimum 5 years of experience in job-related area

Senior Engineer, Validation Examples

1

Senior Engineer, Validation Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of senior engineer, 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 senior engineer, validation
  • Contribute to a robust Computer Systems/Data Integrity Compliance program - a component of the overall GxP audit programs
  • Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations
  • Maintains awareness of current regulatory trends and their impact on the validation status of computerized systems
  • Seeks out and recommends to management opportunities for increased quality system efficiencies and operational improvement through modifications to current systems, implementation of new systems, and more efficient use of established systems
  • Responsible for the technical direction and overall management of the cleaning program at a multiproduct facility
  • Ensure the integration of environmental health, safety, and security into the business processes, systems and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area
  • Identify, construct, and administer system integration test plans to validate the full-system customer solutions for overall signaling solution, including the office, communication, wayside, and on-board systems
  • Develop and guide field teams in the installation, configuration, validation, and commissioning of integrated signaling, communications, and office systems
  • Define and be responsible for the full integration and validation test plans to provide evidence that the integrated system solution meets all system and customer acceptance requirements
  • Define all project level field test cases to verify that all field installation work is compliant with design and meets contractual functional requirements
Qualifications for senior engineer, validation
  • Excellent knowledge of software testing techniques and test case development
  • Excellent experience in structured software development life cycle and validation, (preferably including software
  • Clearly demonstrates an extensive understanding of quality and regulatory compliance the application of these concepts
  • Thorough knowledge of test case design and strategy
  • Get information on the next release of software’s for ECUs, identify testing requirements, hours and costs planned, resources needed for testing in order to plan for the timely validation of the ECU
  • Participate in Functional reviews to make sure that the functionalities defined are testable and a suitable test strategy can be identified
2

Senior Engineer, Validation Job Description

Job Description Example
Our innovative and growing company is hiring for a senior engineer, validation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior engineer, validation
  • Monitor adherence to project plan, schedule, and cost performance
  • Assist in developing and writing processes for process improvement in order to create new opportunities in testing execution
  • Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors
  • Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs)
  • Create and perform statistical process control mechanisms, and monitoring on a periodic basis
  • Review and update the process documentation as necessary
  • Maintains awareness of current regulatory trends and their impact on the validation status of equipment, and processes
  • Validation for wireless products GSM/ GPRS/ EDGE/ UMTS/ LTE/ GPS/ BT/ TCP/IP to ensure quality level before delivery to customers
  • Drive validation projects including define test strategy with R&D/ Project Management/ Product Line Management, plan validation schedule, job assignment to internal validation engineers or 3rd Party
  • Provide technical support to colleagues and sub-contractors
Qualifications for senior engineer, validation
  • Experience in test automation - Preferred
  • Investigate isolated data integrity gaps and events and potentially systemic system issues together with other stakeholders
  • Participate in the Product roadmap discussion to decide on the verification roadmap for the component, ECU, Subsystem
  • Responsible for test reports generated by the test team and product quality
  • Excellent Knowledge of software tools on testing (J1587, CAN, Labview
  • Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
3

Senior Engineer, Validation Job Description

Job Description Example
Our company is growing rapidly and is looking for a senior engineer, validation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior engineer, validation
  • Provide validation services (test and troubleshooting) to customer
  • Test Strategy - Preparations, Reviews
  • Overall responsibility (we work in Scrum) for creation and automation of platform and application component tests
  • Working knowledge of Load Generators like Spirent Test center
  • Hands on experience in test case writing, scripting and defect management
  • Technical background in Video technologies, Encoding/compression techniques, HAS protocols
  • Fast learner, flexible attitude and adaptability to evolving technologies and work profile
  • Supporting product and software validation through development, manufacturing and into continuation providing technical support and leadership on a cross-functional team
  • Define, document, and continuously improve validation tests including conducting peer reviews and maintaining traceability to requirements
  • Interface among multiple departments and teams including R&D, Manufacturing and Quality
Qualifications for senior engineer, validation
  • Hands on experience in generating user requirements and conducting system and process risk assessments, including FMEA generation
  • Demonstrated knowledge of manufacturing of sterile pharmaceutical products and/or drug/device combination product manufacturing
  • Must demonstrate the ability to think critically and analytically with acumen for trouble-shooting and problem solving
  • Ability to function effectively and independently in a fast-paced, dynamic environment
  • Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed
  • Read and interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&I
4

Senior Engineer, Validation Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior engineer, validation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior engineer, validation
  • Design and develop components for pre-silicon validation environment using Verilog, System Verilog and test automation software’s like Simutest and Vtran
  • Generation, Conversion and Verification of test vectors for different ATE platforms
  • Generate ATE Test vectors for Protocols like I2C and SPI using Perl scripting language
  • Development of efficient and accurate automated tests to validate functionality and measure electrical characteristics of low energy integrated circuits
  • Efficient execution of various types of tests
  • Partner and customer interaction
  • Lead and execute validation projects at the Fort Washington site
  • Provide technical input for standards, procedures, risk assessments, and regulatory requirements associated with validation practices and execution
  • Provide input into the Product Life Cycle process as it relates to validation requirements
  • Collaborate within the Technical Operations function including Engineering, Liquids, Solids and Packaging Technology Platforms with Quality functions and the Manufacturing sites to establish and continuously improve validation practices, procedures, performance measures, and areas of process improvement
Qualifications for senior engineer, validation
  • Knowledge of scripting languages, for example, PERL, Python
  • Prior experience in handling a team of 8 to 10 engineers of varied experie
  • Hands on experience in all QA process – Agile & waterfall
  • Knowledge on test case and defect management tools like Testlink, JIRA, Bugzilla, HPQC etc
  • Should be a fast learner, flexible attitude and adaptability to evolving technologies and work profile
  • Should be a good communicator and a dependable team player
5

Senior Engineer, Validation Job Description

Job Description Example
Our innovative and growing company is looking for a senior engineer, validation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior engineer, validation
  • Present validation execution strategies, deviations, outcomes and metrics to the site VRC and attend or participate in any other VRC meetings as needed
  • Maintain technical training/knowledge in applicable functional area
  • Participate in establishing consistent, harmonized, validation processes and procedures across Company Consumer Healthcare OTC businesses and manufacturing sites
  • Authors standard operating procedures
  • Participates in cross-functional teams to lead and execute projects continue improvement in validation practices and procedures
  • Inform direct Management of validation state and issues requiring prioritization
  • Document Validation activities in reports following required procedures and templates
  • Review validation documentation for content and GDP
  • Provide technical support to investigations and resolution of process deviations including complex investigations
  • As applicable, provide supervision and/or guidance to engineers with less experience
Qualifications for senior engineer, validation
  • Owning Quality Systems Records
  • Bachelors’ Degree in science or engineering, from an accredited university or college
  • Greater than a minimum of ten (10) years’ experience)of relevant cGMP biopharmaceutical manufacturing environment experience in either validation, quality systems, operations, engineering or any combination thereof
  • Of the experience, at least 5 years must be recent experience with validation to qualify typical bulk manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility
  • Experience in two or more validation disciplines (Equipment/System Qualification, Utility, Laboratory, Automation and/or computer Systems) with proficient technical knowledge
  • Knowledge of Validation Lifecycle Approach

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