Sterile Validation Specialist (Engineer II)
|North Carolina - United States
$90,000.00 - $100,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Validation Specialist (Sterile – Injectable and Blow Fill Seal) to join its growing team in the Charlotte NC area. The Validation Engineer/Specialist will plan and schedule qualification projects, including the ability to develop, perform, maintain, and support qualification activities and documentation in accordance with cGMP requirements. Provide support to the vendor’s installation and qualification activities.
- Qualification of Sterile – Injectable and BFS manufacturing facilities and equipment in compliance with FDA regulations, Quality management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) requirements.
- Experience in Equipment, Utility and Facility Qualification in GMP environment. This position will interface with clients, lead team members of Qualification, Engineering, Operations and QA professionals.
- Provide subject matter expertise in the qualification process of a variety of utility, facility and process equipment.
- Responsible for preparing and executing qualification documents for a variety of Utility, Facility and Process/Packaging equipment. This includes Factory Acceptance Testing, User Requirement Specification, System Impact Assessment, Design Qualification, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, and Periodic review of equipment qualification status.
- Develop qualification protocols and reports for the Facility, Manufacturing Equipment, Packaging Equipment, Utilities.
- Assist in the generation of User Requirement Specification and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system.
- Assist in creating the Standard Operating Procedures for manufacturing/packaging equipment and qualification related procedures.
- Able to follow-up and resolve comments, deviations, and technical issues with the qualification activities.
- Provide support in generation of Master Validation Plan. Ensure it is current and the scheduled activities being implemented per agreed timelines.
- Must be able to work independently and in team environment to conduct qualification activities using a science and risk based approach.
- 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.
- 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.
- Support in presenting and defending qualification protocols/reports during regulatory inspections and internal audits.
- Bachelor's degree in relevant scientific discipline (Engineering, Chemistry or Science) required. Equivalent experience will be considered.
- Minimum of 3 years of experience in qualifying the Sterile – Injectable and Blow Fill Seal manufacturing equipment and Facility required. 7 years of overall experience is preferred.
- Must have excellent verbal communication and technical writing skills.
- Must have experience with aseptic gowning requirements and Clean room qualification.
- Must have experience with usage of data loggers and Kaye Validator.
- Hands-on experience in project planning, development, and execution of pharmaceutical equipment qualification protocols/reports for Sterile manufacturing equipment (Compounding, and Filtration Vessels), Autoclave, Lyophilizer, Vial Filling Line (Washer, Filler, Depyrogenation Tunnel) Vial Labeler, CCIT, Serialization and Aggregation, Pre Filled Syringe Line (PRILM), BFS (Filling, Deflashing), Pouching Machine and PFS Labeler.
- Hands on experience with interpreting P&ID’s, Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, equipment/system layouts, wiring diagrams, and specifications in planning and performing qualification activities.
- Demonstrated experience with process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, CIP/SIP sequences.
- Familiarity with qualification of Purified Water System, Compressed Air, Nitrogen Gas, Water for Injection, Pure Steam, HVAC/AHU, EMS/BMS system.
- Familiarity with statistical knowledge of ANSI/ASQ sampling scheme, Control Limits and Process Capability Analysis is preferred.
- Excellent knowledge of pharmaceutical quality systems and Qualification practices.
- 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.
- Proficient in Microsoft Word, Excel, Power Point and Project.
University - Bachelor's Degree/3-4 Year Degree