Johnson Service Group (JSG) is currently looking for a Packaging / Assembly Line validation SME. This is a long-term contracting opportunity with a world leading pharmaceutical company located in Albany, NY.
Hourly rate $60.00
 
Responsibilities: Generate and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sealing rooms and manufacturing equipment. Develop comprehensive validation packages, including Validation Plans, User Requirement Specifications (URS), Functional Design Specifications (FDS), and IQ/OQ protocols, specifically for color vision inspection systems, blister packaging machines, and form fill finish lines. Draft and review equipment qualification protocols using the Validation Master Plan (VMP). Author and execute validation plans for cartoners, blister packaging machines, and fillers is a plus. Perform vendor protocol assessments to identify and address gaps in vendor-provided IQ/OQ protocols. Review and approve Quality Management System (QMS) documents related to various projects, including Standard Operating Procedures (SOPs), Material and Product Specifications, Master Production Records, and Validation Protocols and Reports. Manage Quality Assurance (QA) aspects of cGMP manufacturing projects, acting as a QA Representative. Develop and implement effectiveness check plans to assess the effectiveness of closed Corrective and Preventive Actions (CAPAs). Perform document reviews and GAP analysis to ensure compliance with QMS and Quality System Regulation (QSR). Support the writing and review of technical documents for equipment qualification. Qualifications: Proven experience in generating and executing IQ/OQ/PQ protocols for packaging and assembly equipment. Strong background in developing validation packages and drafting equipment qualification protocols. Experience with color vision inspection systems, blister packaging machines, and form fill finish lines. Familiarity with cGMP regulations and quality management systems. Demonstrated ability to manage QA aspects of manufacturing projects and develop effectiveness check plans for CAPAs. Proficient in performing GAP analysis and document reviews to ensure compliance with QMS and QSR. Excellent technical writing skills for creating and reviewing validation documentation.   
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.