No Visa sponsorship
Must have Sterile Experience from pharma manufacturing environment
· 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.
· 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.