Validation Specialist

Glenmark is 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 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.
• Review completed protocols for completeness, cGMP compliance and data acceptability.
• Provide support in generation of Master Validation Plan. Ensure it is current and the scheduled activities being implemented per agreed timelines.

• Support in presenting and defending qualification protocols/reports during regulatory inspections and internal audits.
• Assist in creating the Standard Operating Procedures for manufacturing/packaging equipment and qualification related procedures.
• Must be able to work independently and in team environment to conduct qualification activities using a science and risk based approach.
• Able to follow-up and resolve comments, deviations, and technical issues with the qualification activities.

• Must be able to lead project with minimal supervision.
• Coordinate the proper approval of plans, requirements, and protocols.

• 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.