Validation Engineer

About the role

The Validation Engineer will assist with the development and execution of validation protocols for various types of processes. Key responsibilities include generating and executing life cycle documentation, supporting validation activities, writing and reviewing technical documents, and performing execution support activities.

Responsibilities

• Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
• Support validation activities for client projects, including generation, execution, review, and closure of validation life cycle documents.
• Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures, investigations, protocols, reports, change controls, etc., to support the execution and closeout of validation work.
• Perform execution support activities including P&ID walkdowns, drawing reviews, and ETOP verification.
• Perform thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

Qualifications and requirements

• Education: Bachelor’s degree in a related life science field.
• Technical Experience: 3-10 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. Hands-on equipment start-up and troubleshooting experience is highly desired. Report writing experience for IQ, OQ, PQ.
• Knowledge, Skills, and Abilities: Strong verbal and written communication skills and the ability to discuss technical topics with stakeholders and non-technical people is strongly desired.