Sr Process Engineer, Global Technical Operations - Sterile & Validation Center of Excellence job in West Point
|Employer:|| Merck & Co.|
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 incumbent will be part of the Global Technical Operations - Sterile & Validation Center of Excellence, a technical operations group that has global responsibility for pharmaceutical manufacturing technology and validation subjects. In the Packaging Component Engineering role, the incumbent will provide technical leadership for design, sourcing, and operational support projects related to primary packaging components. This role will require collaboration and global coordination of work across Operations, Packaging Technology, Quality, Supplier Development & Performance Management, Planning, and Procurement. Responsibilities contain technical, regulatory, and business elements.
The incumbent will be responsible for projects and activities related to sterile product packaging including vials, stoppers, syringes, cartridges, and tubes. Areas of focus will include support for new component selection, sourcing, and implementation; visual inspection; deployment of standard components and practices; assistance with process deviation investigations; process and productivity improvement projects, and supplier change management.
Responsibilities include, but are not limited to, the following:
• Act as a global subject matter expert for Primary Packaging Components (PPCs); this expertise must span the component supplier manufacturing processes through the Merck manufacturing processes;
• Develop standards and practices to resolve and avoid primary packaging component problems;
• Support visual inspection defect defition and defect criticality assessments.
• Coordinate activities and provide technical oversight with suppliers to improve the quality and supply of components to support World Class Supply of vaccines and sterile products; Participate in business and relationship review meetings;
• Evaluate supplier changes for impact to Merck business; generate required documentation in change control systems and support related site activities;
• Lead assessments to identify and mitigate risks of new components; Manage prequalification testing program including fit for use testing, piloting work, or other characterization studies to assess component suitability;
• Design effective corrective and/or preventive actions as required for individual investigations or deviation trends.
• Lead process improvement efforts that involve PPCs.
• Work internally and externally to develop best practices and standards for the industry.
Education Minimum Requirement:
• B.S./M.S./Ph.D. in engineering or science discipline Required Experience and Skills:
•Minimum 3-5 years in pharmaceutical manufacturing or technical support roles
•Technical problem-solving abilities
•Strong communications, planning and collaboration/negotiation skills
•Technical writing proficiency
•Ability and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the time
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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