Validation Engineer II

BEPC has an open position for a Validation Engineer II Location: South San Francisco, CA Requisition ID: ROCGJP00022782 W2 Contract Length: 1 year contract with possibilities for extensions Benefits: Medical, Dental. Vision and Life Insurance Pay Range: $58 – 74/hr. Description: The 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. · 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) · Execute system periodic reviews. · Initiate and manage discrepancy and change management process. · Regularly interact with external development partners and equipment suppliers, Quality, and IT group. General: · 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 team 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/risk management documents 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. · Employ good document practices (GDP) when recording data, performing qualification/validation activities, maintaining archives and drafting and reviewing documents. Skills: · 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. · Excellent oral and written communication skills · Knowledge of cGMPs or equivalent regulations · Ability to understand and independently apply cGMPs and /or GLPs to everyday work with regard to documentation and laboratory equipment. · Experience in computer system validation is a plus. · Knowledge of biopharmaceutical regulations such as FDA, cGMP, and 21 CFR Part 11 Education / Requirements: · B.S. degree in Science or Engineering and at least 1-2 years of experience in the pharmaceutical or biopharmaceutical industry. · Onsite availability for work required. At minimum 3 days per week or as requested by the team lead. Job Type: Contract Pay: $58.00 - $74.00 per hour Benefits: Dental insurance Health insurance Life insurance Vision insurance Schedule: 8 hour shift Work Location: In person