Validation Specialist

Validation Specialist - Contract - New Brunswick, NJ - $42.00-$52.00/ Hr.The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.A Pharmaceutical Company is seeking a Validation Specialist in New Brunswick, NJ.Role DescriptionProvides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Bristol Myers Squibb (BMS) Co. and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with company internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls).• Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP''s), authoring and executing Risk Mitigation Plans as needed• Determines disposition of drug products according to BMS and regulatory specifications and standards• Review change requests generated internally or by External Manufacturer• Reviews Annual Product Quality Reviews (APQR''s) authored by Contract Manufacturers/Packagers and supplement APQR''s as required• Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA''s) and provide direction and recommendations as to future course(s) of action• Review Quality Agreements• Review and approve product quality complaint investigations• Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements• Write, review and implement SOP''s to ensure compliance with current BMS standard and current Good Manufacturing Practices (cGMP)• Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)• Supports product recalls and executes plan as assigned• Represent Bristol Myers Squibb during FDA/other regulatory inspections and corporate Good Manufacturing Practices (GMP)compliance audits as defined in related Quality Agreements• Assist with preparation of audit observations• Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and European Medicines Agency (EMA) cGMP regulations and policies• Represent Quality on cross-functional teams within the ''Virtual Manufacturing Plant'', Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teamsSkills & Requirements• Knowledge in solid dosage forms, parenteral technology, biologics or combination products• Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them• Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))• Good verbal and written communication skills essential• Excellent interpersonal skills• Capable to manage multiple priorities• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met8.Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems• B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent• A minimum of five (5) years'' experience in pharmaceutical, biologics, biotech or related industry with relevant experience• Experience in a Quality Assurance, Quality Control or equivalent function is required• Experience in the manufacture of drug substance and/or drug product or quality control laboratoriesWhy Hays?You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there''s a position you really want, you''re fully prepared to get it.Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.• Medical• Dental• Vision• 401K• Life Insurance ($20,000 benefit)Nervous about an upcoming interview? Unsure how to write a new resume?Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.Hays is an Equal Opportunity Employer including disability/ accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570Drug testing may be required; please contact a recruiter for more information.

Created: 2025-09-06