Location: Waltham, MA
Department: Azzur of NE, LLC
Department: Azzur of NE, LLC
Essential Duties and Responsibilities:
- Generate and execute life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/QC lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish) computer systems, automation and processes (cleaning, sterilization, shipping) for qualification/requalification.
- Review, advise on and contribute to change control documents. Provides sound validation/verification assessments.
- Write, review and revise a variety of Commissioning and Qualification protocol related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design review, or other technical documents such as user requirement specifications (URS), system classification, system risk assessments, 21 CFR Part 11 compliance assessment, functional requirement specifications (FRS), detailed design specifications, and/or commissioning test procedures.
- Writes summary reports to summarize Commissioning and Qualification testing.
- Writes procedures, investigations, change controls, etc. to support the validation lifecycle documentation.
- Develops and executes validation plans and protocols for Process Performance Qualification (PPQ), mixing validation, L&E, materials qualification and other manufacturing processes.
- Work with contractors and equipment vendors, as necessary, to ensure validation packages are provided and completed to the required standards, on schedule.
- Performs P&ID Walkdowns, installation and operational tests for equipment and utilities. Performs Thermal mapping of temperature controlled chambers, (refrigerator, freezers, incubators, cryo storage) warehouses, and SIP processes
- Initiates and performs investigations to close out protocol discrepancies and deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues.
- Provides assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
- Work independently to collect, organize and evaluate validation data and review work of other engineers in the team. Keep validation management informed about the progress and any obstacles.
- Collaborate well with the cross-functional team and work efficiently in a team environment. Communicate effectively with management, stakeholders, regulatory agencies and vendors. Assists in providing training to other engineers in the team.
- 4-8 years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, cell and gene or medical device industry
- Hands on experience in executing C&Q protocols for facilities, utilities and manufacturing/ QC lab equipment and processes.
- Experience in Quality or QAV is desired.
- Strong knowledge of FDA, EU and cGMP regulations and good documentation practices
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
- Proficient in Microsoft Word, Excel, Project and PowerPoint