Merck Associate Director, Engineering in West Point, Pennsylvania
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.
The function of this position is to provide engineering technical support to the manufacture of polysaccharide vaccines. The primary role will be to serve as Technical Lead for Polysaccharide bulk Vaccines, providing solid line management to a team of engineers responsible for unit operation support of the bulk vaccine manufacture. In addition, the role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be in one area or span across multiple areas of focus.
Responsibilities include, but are not limited to:
Soild Line Management – Providing oversight and leadership to a team of support engineers. Coordinate availability of all resources including people, material and supplies to enable right first time execution of the pneumococcal polysaccharide polyvalent bulk.
Serving as the process Subject Matter Expert (SME) for bulk polysaccharide vaccines during all regulatory inspections and internal audits.
Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
Leading investigations specifically aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Leading project teams to implement changes for process improvement, compliance, and strategic, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.
Authoring and/or approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.
Preparing source documentation for regulatory filings and supporting requests for regulatory inspections related to process overviews, investigations, projects and validation. Serving as Liason to a candidate pneumococcal polysaccharide vaccine.
Authoring/Approving technical protocols, executing studies and reporting results/conclusions in support of product tech transfers, process improvement projects and deviation investigations. The individual will be required to utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).
Supporting team safety, environmental, and compliance objectives.
Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Mechanical Services, Automation, Technology), Quality, and Planning.
Education Minimum Requirement:
- Bachelor's Degree in Chemical Engineering or Biological Science or other appropriate science or engineering field.
Required Experience and Skills:
Minimum of 5-year post-Bachelor’s degree experience in support of Production, Validation, Process Engineering, Technical Services or related experience.
Minimum of 3 years of hands on experience with manufacturing scale production support of in-line vaccine manufacture.
Support of vaccine operations and product franchise technical services support.
Demonstrated ability to work both independently and as a part of a team.
Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills.
Preferred Experience and Skills:
Experience with regulatory audits/inspections.
Experience with Trackwise, MIDAS, SAP, Delta V
Experience with tech transfer
Support of deviation investigations and/or project work
LSS/MPS certification / experience
Minimum of 2 years of people management experience, either dotted-line or solid-line experience.
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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Visa sponsorship is not available for this position.
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Job Chemical Engineering
Title: Associate Director, Engineering
Primary Location: NA-US-PA-West Point
Requisition ID: CHE006236