Validation Engineer (Contractor) Jobs

The Position

Description
Genentech's Device Development team is searching for a Validation Engineer to assist, lead, and execute validation activities (e.g., equipment qualification, computer system validation) and manage discrepancies and changes to Qualified/Validated systems.

The candidate should have knowledge in Laboratory equipment qualification & validation process, data integrity (CFR Part 11 Compliance) implementation, cGMP documentation, Change Management, and operational maintenance of Laboratory equipment.

Responsibilities
The Validation Engineer will work in the Laboratory Operations group and collaborate across functions (e.g., quality, IT, and vendors) to lead, assist, and execute validation activities (e.g., equipment qualification, computer system validation).

This objective will be accomplished by executing the following activities:

• Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g., hardware, software, and accessory systems) for use in regulated and non-regulated operations.
• Execute system periodic reviews.
• Initiate and manage discrepancy and change management process.
• Author/ review commissioning and qualification documents throughout system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocol/report, and support documentation (e.g., IQ, OQ, PQ, traceability matrices, SOP, maintenance plan)
• Regularly interact with external development partners and equipment suppliers, Quality, and IT group.

General

• Create and review discrepancy, change/risk management documents as appropriate.
• Ensure compliance of training to PQS and job-related requirements.
• Support the team lead in preparing communications for internal review committees.
• Employ good document practices (GDP) when recording data, performing qualification/validation activities, maintaining archives and drafting and reviewing documents.
• Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards.
• Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
• Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
• 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.

Skills

• Knowledge of cGMPs or equivalent regulations
• Knowledge/experience of Computer System Validation (CSV) requirements and procedures for lab instrumentation and instrument qualification (IQ/OQ/PQ)
• Ability to work in a team, highly organized, detail oriented, work independently, and manage project priorities
• Experience in computer system validation is a plus.
• Excellent oral and written communication skills
• Ability to understand and independently apply cGMPs and /or GLPs to everyday work with regard to documentation and laboratory equipment
• Knowledge of biopharmaceutical regulations such as FDA, cGMP, and 21 CFR Part 11.

Education / Requirements

• Onsite availability for work required. At minimum 3 days per week or as requested by the team lead.
• B.S. degree in Science or Engineering and at least 1-2 years of experience in the pharmaceutical or biopharmaceutical industry.

The pay rate range for this role is $58.05/hr -$75.19/hr.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.