The employee is responsible for the startup, commissioning and qualification of various facilities, utilities and process/equipment systems. Ensures compliance with relevant regulatory agencies in all validation activities. Startup responsibilities include coordinating vendor SAT support, system troubleshooting, commissioning and operational qualification of equipment.
- Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
- 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
- Writes, and executes protocols, resolves deviations/ discrepancies, reviews, and analyzes study data, writes summary reports.
- 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.
- Provides assistance with project management for commissioning, qualification of new engineering systems.
- Bachelor’s Degree in engineering, science, or similar field.
- 1-3 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 DeltaV distributed control system.
- 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 interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Proficient in Microsoft Word, Excel, and PowerPoint
- Master’s degree in engineering, science, or similar field.
- Experience with temperature mapping.
- Experience with many aspects of validation.
- Experience with use and/or qualification of laboratory instruments.
- Experience with use and or qualification of Laboratory Information Management System (LIMS) such as SampleManager or LabWare LIMS.
- Working knowledge of FDA and cGMP regulations and documentation practices.
- Familiarity with temperature mapping.
- Familiarity with executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop