South San Francisco, CA, USA | Genentech
Industry:Pharmaceutical / Biotech
Job Description:55 people have viewed this job
The Validation Engineer will work collaboratively across functions (e.g. quality, IT, and vendors), assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and lead and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer. The candidate will work with general direction and may also supervise staff members. This objective will be accomplished by executing activities in the areas of:
Equipment Qualification and Computer Systems Validation
-Implement and coordinate commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
-Author commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
-Review laboratory requirements and define procedures for instrument and data management/data integrity.
-Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
-Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
-Regularly interact with external development partners and equipment suppliers, Quality, and IT group.
-(Test) Method Validation
-Lead and execute test method validation and method transfer, and develop new test methods as required by projects.
-Apply Measurement System Analysis statistical approaches such as Gage R&R for validation of new methods.
-Perform First Article Inspection and design fixtures as needed.
-Author, review and/or approve validation documents to support device development deliverables such as protocols and report, test methods, and risk assessments.
-Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
-Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
-Support the laboratory lead in preparing communications for internal review committees.
-Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
-Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
-Ensure compliance of training to PQS and job-related requirements.
-Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards and DHF regulations.
-Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
-Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11.
-Knowledge of CSV requirements and procedures for laboratory instrumentation and instrument qualification (IQ/OQ/PQ).
-Knowledge of Measurement System Analysis (MSA) and statistical analysis
-Working knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
-Knowledge of Design Controls for regulatory compliance & filing (ISO 13485, etc), GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, etc..
-Six Sigma (Green/Black Belt): DMAIC and DFSS.
-Excellent oral and written communication skills
-Ability to work in a team, highly organized, and detail oriented
-B.S, M.S, Ph.D or advanced degree in Engineering.
-At least 5 years of related industry experience
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