Senior Specialist Engineering, VMP SME
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 Senior Specialist Engineering SME, will be responsible to ensure new/initial validation projects are in alignment with the West Point site standard/guidelines as part of the Bio-Sterile Validation (BSV) Subject Matter Expert (SME) team. The primary responsibility of the individual will be supporting the Integrated Product Teams (IPTs) in vaccine manufacturing with projects and strategies to ensure execution complies with Merck requirements and regulatory expectation. The Senior Specialist will review and approve validation documentation (including but not limited to; validation strategies, detail design, user requirements document) related to new or existing projects to ensure successful completion is in alignment with west point validation requirements. The Senior Specialist will be required to train and coach junior engineer/specialist in general validation areas such as sterilization, cleaning validation equipment qualification, utilities and facility qualification among others.
Additional responsibilities include the following:
- Support/leads/consult multiple mid-sized or large projects on behalf of Validation COE.
- Defend site and company validation policies/practices in front of regulatory agencies during inspections and regulatory submissions related to validation master plan and major projects implementation (e.g. capital projects, improvement projects..etc). Support IPT customers on new or existing projects phases such as design, implementation and maintenance phases.
- Generate and approve validation assessment for new or existing changes to equipment/facility/utility and component when necessary.
- Support site troubleshooting activities during investigation and process improvement activities.
- Complete gap assessments for Merck global guidance and perform remediation activities to ensure site compliance.
- Support site IPTs during investigations associated to projects and communicate with management to identify proper SME to support activities.
- Interface with global validation group to ensure validation practices are aligned across Merck & Co., Inc. network.
- BS, Preferably in Engineering or Sciences
- Minimum of 7 years relevant work experience, hands on experience on general validation activities and in sterile products manufacturing and/or laboratory operations.
- Strong knowledge and hands on experience validation project management.
- Demonstrate strong knowledge on different types of validation such as but not limited to: cleaning, sterilization, utilities, facility and equipment qualification.
- Strong communication, collaboration skills and ability to drive accountability
- Demonstrated experience in utilization of Project Management Principles.
- Strong background solving analytical and or complex problems.
- Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).Experience writing validation strategy for large and small validation projects.
- Minimum of 5 years work experience on managing validation projects for manufacturing and/or laboratory operations.
- Experience interacting with regulatory agencies.
- Experience with Risk-Based Approach to Commissioning and Qualification.
- Strong experience working on cross functional team to achieve common goal.
- Project Management Professional (PMP) certification.
In accordance with "Manager's Policy" - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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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Job: Engineering Generic
Employee Status: Regular
Number of Openings:
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Company Trade Name: Merck