Department: Azzur of Worcester, LLC
Azzur Group is looking for a Senior Validation Engineer to join our growing team. The person in this role will be responsible for the startup, commissioning and qualification of various facilities, utilities and process/equipment systems while ensuring compliance with relevant regulatory agencies in all validation activities. Startup responsibilities include coordinating vendors SAT support, system troubleshooting, commissioning, and document management.
- Generates and executes life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish) computer systems, automation, and processes (cleaning, sterilization, shipping) for qualification/requalification.
- Reviews, advises on, and contributes to change control documents. Provides sound validation/verification assessments.
- Writes, reviews and revises 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, commissioning, qualification or other technical documents such as user requirement specifications (URS), System Classification, System Risk Assessments, 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
- 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.
- 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.
- 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.
- Provides assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
- Collaborates well with the cross-functional team and work efficiently in a team environment. Communicates effectively with management, stakeholders, regulatory agencies and vendors. Assists in providing training to other engineers in the team.
- Bachelor’s or Master's Degree in engineering, science, or equivalent technical degree
- 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/lab equipment and processes. Experience with cycle development for cleaning and sterilization, automation/CSV and temperature mapping
- 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
- Strong interpersonal skills and the ability to work in a team environment with attention to detail