Responsibilities:

• Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
• Supporting validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
• Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification 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.
• Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
• Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
• Supports the resolution of regulatory observations or manufacturing site issues.
• Executing periodic reviews and requalification for temperature chambers.

Requirements

• Bachelors Degree in engineering, science, or similar field.
• 2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
• Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
• Experience with temperature mapping.
• Working knowledge of FDA and cGMP regulations and documentation practices.
• Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.
• Milliflex Oasis Filtration - Support Instrument Qualification, IQ/OQ/PQ
• Future state and work in the pipeline: Isolator, BACTAlert and EMPQ.