Glenmark is actively seeking a Senior Validation Specialist to join the growing team in Monroe, NC. Planning the site validation activities to meet organizational business requirements and regulatory specifications. Responsible for preparing and executing qualification documents for a variety of Utility, Facility and Process/Packaging equipment including 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. Assist in creating the Standard Operating Procedures for manufacturing/packaging equipment and qualification related procedures. Assist in the development of qualification protocols and reports for the Facility, Manufacturing Equipment, Packaging Equipment, Utilities. Provide subject matter expertise in the qualification process of a variety of utilities, facility, and process equipment. 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. Interface with clients, assisting in leading team members of Qualification, Engineering, Operations and QA professionals.

• 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.
• 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
• Work independently and in a team environment to conduct qualification activities using a science and risk-based approach
• 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 from time to time
• . Contribute to department efficiency initiatives
• . Support in presenting and defending qualification protocols/reports during regulatory inspections and internal audits.

Qualifications and Requirements

• Applicant must have a Master’s Degree (or U.S. equivalent) in Validation Engineering, Pharmaceutical Chemistry, Chemistry or Pharmaceutical Sciences plus 2 years of experience in Quality Assurance and Validations of Sterile formulations, equipment, and facility in the pharmaceutical industry or in the alternative Bachelor’s Degree (or U.S. equivalent) in Validation Engineering, Pharmaceutical Chemistry, Chemistry or Pharmaceutical Sciences plus 5 years of experience in Quality Assurance and Validations of Sterile formulations, equipment, and facility in the pharmaceutical industry.
• Must have experience with aseptic gowning requirements and clean room qualification and 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.
• Knowledge of Purified Water System, Compressed Air, Nitrogen Gas, Water for Injection, Pure Steam, HVAC/AHU, EMS/BMS system is required.
• Statistical knowledge of ANSI/ASQ sampling scheme, Control Limits and Process Capability Analysis is required.
• Excellent knowledge of pharmaceutical quality systems and Qualification practices. Must have excellent verbal communication and technical writing skills.

40 hours per week:

Monday - Friday: 9am-5pm

Must have proof of legal authority to work in the United States