Pharmaceutical manufacturer on the south side of Charlotte, NC. Strong growth potential and very active team/family environment.
We are seeking a Validation Specialist to 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,
? 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
? Bachelors 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.?