Client will help with relocation
- Qualification of Oral Solid Dose (OSD) and Sterile manufacturing facilities.
- Maintain all documentation pertaining to qualification and validation.
- Experience in Equipment and Facility Validation and / or Qualification in GMP environment. This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
- Responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle document
- Generate equipment/cleaning validation documents.
- Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.
- Develop/review requirements and specifications.
- Able to follow-up and resolve comments, deviations, and technical issues.
- Generate/execute variety of commissioning and qualification protocols for pharmaceutical equipment(IQ, OQ, PQ).
- Must be able to work independently and in team environment.
- Must be able to lead project with minimal supervision.
- Coordinate the proper approval of plans, requirements, and protocols.
- Review completed protocols for completeness, cGMP compliance and data acceptability.
- Prepare validation summary and final reports.
- Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems.
- Develop a strong documentation package, involving form conceptual study to various phases of projects like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
- Qualification and documentation related to engineering department.
- Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
- Contribute to department efficiency initiatives
- Bachelor's degree in relevant scientific discipline required
- Equivalent experience will be considered
- 3-7 years of experience
- Hands-on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
- Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc of biopharmaceutical processes.
- Demonstrated experience with process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, CIP/SIP sequences.
- Experience reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation.