- Lead the qualification program of Sterile – Injectable and BFS manufacturing facilities and equipment in a manner that meets with FDA regulations, Quality management systems, Good Manufacturing Practices (21CFR Part 210 and 21CFR Part 211) and 21 CFR Part 11 (Electronic Records and Signatures) requirements.
- Provide oversight, direction and lead projects by writing, executing, or providing oversight to contractors or junior team members for qualification activities, Change Control Management, Periodic review and Deviation Management.
- 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.
- Provide technical advice on new equipment, utility and processes. Able to follow-up and resolve comments, deviations, and technical issues with the qualification activities.
- Generate Master Validation Plan and procedures related to qualification. 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.
- Responsible for compliance with applicable corporate and site policies and procedures.
- Responsible for presenting and defending qualification protocols/reports during regulatory inspections and internal audits. Support any gap remediation activities.
We are actively seeking a Senior Validation Specialist (Sterile – Injectable and Blow Fill Seal) to join its growing team in the Charlotte NC area. The Senior 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.
- Bachelor's degree in relevant scientific discipline (Engineering, Chemistry or Science) required.
- Equivalent experience will be considered
- Minimum of 5 years of experience in qualifying the Sterile – Injectable and Blow Fill Seal manufacturing equipment and Facility is a must. Preferred overall experience in Pharmaceutical industry is 10 years.
- Must have excellent verbal communication and technical writing skills.
- Must have experience with aseptic gowning requirements and Clean room qualification. Media fill simulation or qualification experience is preferred.
- 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.
- Strong ability to work in a fast pace team environment and collaborate effectively with other stakeholders.
- Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
- Possess a positive and get it done attitude and high degree of flexibility and adaptability.