Responsibilities
- The Validation Specialist is responsible for 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.
- 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.
- Relocation provided. $70K-$85K.
Requirements
- The Validation Specialist will have a BS degree in a scientific discipline.
- 3+ years hands-on experience in conceptual, detailed design, project planning, execution and qualification of bio pharmaceutical 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 bio pharmaceutical processes.
- Demonstrated experience with process valve matrix, process sequence logic, 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.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.