Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As part of the MerckManufacturing Division (MMD), Durham BioSterile Validation is seeking a highlymotivated individual to partner with the Operations, Quality Operations, TechnicalOperations and the Focus Factory to meet the targeted supply and complianceinitiatives within the Durham manufacturing site. Specifically, you will be responsible forproviding validation support in the production of current and new vaccines inthe Global Vaccine and Sterile Manufacturing organization.
In this role youwill:Provide documented evidence that processes areconsistent and reliable through challenges against pre-establishedcriteria. Support validation activities associated with thedevelopment of new products, processes, systems, and facilities andsupport of existing and new products, processes, and facilities. Provide technical support to help develop andexecute project plans, and obtain and analyze relevant data and prepareappropriate reports for regulatory commitments and validation improvementinitiatives. May be responsible for leading teams toefficiently accomplish project goals.Provide contributions to the planning, design, and implementationof segments of new or upgraded facilities and equipment in a costeffective and timely manner. Prepare and/or provide review and guidance for regulatory filings,process descriptions, deviation investigations, and change requests.Design validationstudies, author and approve protocols, and ensure alignment with corporatestandards and guidance for validation.Serve as a mentorfor less experienced employees in the BSV team, assisting them in theirtechnical development.Develop technicaland manufacturing documents necessary for engineering studies, processdemonstration, and validation.Participate inthe facility startup and process demonstration activities, primarilydevelopment and performance qualification (PQ) through process validation,working alongside operations team members to develop reliable, consistentmanufacturing processes that meet cGMP requirements.Assist inauthoring the regulatory submission for the facility and present your workto multiple regulatory agencies throughout the pre-approval inspectionprocesses.Assist withtroubleshooting and effectively resolving problems. Develop and implementcorrective actions to unplanned (atypical) manufacturing events to ensurea consistent and reliable supply and prevent recurrence. The successfulcandidate should be able to examine an issue from diverse perspectives (safety,compliance, automation, equipment, process, and people) in order to bestunderstand and resolve it at root cause. Maintainalignment with internal technical personnel regarding validation practicesfor products, processes and equipment. Partner withOperations, Quality, and Automation functional areas on validation studyimplementation. Qualifications
Education Minimum Requirement: B.S. in Engineering or Science
RequiredExperience and Skills: A minimum of 5 years direct validation experience (B.S. degree), 3 years validation experience (M.S. degree) in biological, pharmaceutical, or chemical manufacturing support roles.
Preferred Experience and Skills: Demonstrated ability to work both independently and as a part of a team Experience leading small groups in a GMP environment Familiarity with regulatory requirementsExperience interacting with regulatory agencies Strong technical problem-solving abilities Demonstrated effective written and verbal communication skills; ability to influence both peers and management in building consensus Strong collaboration and leadership skills Sterilization validation (SIP, autoclaves, depyrogenation, VHP, gamma) Cleaning validation (CIP, COP) Controlled Temperature Unit validation (warehouses, incubators, freezers, refrigeration units) Other validation experience in support of process demonstration (IQ/OQ/PQ, shipping, transportation, container closure, sterile filtration, PPQ) Sustaining the validated state through change management and continuing validation studies
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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