Glenmark is actively seeking a Validation Specialist to join its growing team in Monroe, NC! The Validation Specialist will plan and schedule validation projects, including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGMP requirements. Provide support to the vendor’s installation and commissioning activities.
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 initiative
Bachelor's degree in relevant scientific discipline required
Equivalent experience will be considered
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.
Excellent knowledge of pharmaceutical quality systems and Qualification practices.
Strong understanding of aseptic filling unit operations, controls, and drug product process validation is highly desired; a good understanding of resource forecasting is also highly desired.
Ability to work in a team structure; plan, organize and prioritize work.
Ability to analyze quantitative data, create and/or edit written reports and be able to process information.