Sr. Specialist Engineering, CTU 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, will beresponsible for the oversight the controlled temperature mapping (CTU)practices in the West Point site as part of the Bio-Sterile Validation (BSV)Subject Matter Expert (SME) team. Theprimary responsibility of the individual will be supporting Integrated ProductTeams (IPTs) involved in vaccine manufacturing. Also, when required the Senior SpecialistSME will be required to train and coach junior engineer/specialist in areassuch as temperature mapping for freezer, cold vaults, warehouse and laboratorytemperature units.
Additional responsibilities include thefollowing:
- Responsiblefor defending site and company validation policies/practices in front ofregulatory agencies during inspections and regulatory submissions.
- Generateand approve validation assessment for changes to validated state of control forequipment and component
- Supportsite troubleshooting activities during investigation and process improvementactivities.
- TheSME is responsible to ensure the West Point site is in compliance with Merckglobal guidelines
- Completegap assessments for Merck global guidance and perform remediation activities toensure site compliance.
- Supportsite IPTs during investigations as a controlled temperature mapping subjectmatter expert.
- Supportand oversee CTU revalidation metrics for site compliance
- Providevalidation strategy support for implementation of new Units (e.g. site capitalprojects) by reviewing and approving validation related documents when requiredto ensure West Point compliance.
- Interfacewith global validation group to ensure validation practices are aligned acrossMerck & Co., Inc. network.
- Supportnew or existing product regulatory filing requirement and provide subjectmatter expertise review throughout the process.
Education Minimum Requirement:
- BS, Preferably in Engineering or Sciences
Required Experience and Skills:
- Minimumof 7 years relevant work experience, hands on experience on controlledtemperature units system validation in sterile products manufacturing and laboratory operations.
- Strong knowledge on regulatory expectation for temperature-controlled systems (e.g. EU, FDA)
- Strongknowledge and hands on experience calculating and interpreting data fromvalidation studies
- Demonstratestrong knowledge on different types of control temperature units andtemperature mapping concepts
- Strongcommunication, collaboration skills and ability to drive accountability
- Strongbackground solving analytical and/or complex problems
Preferred Experience and Skills:
- Minimumof 5 years work experience on managing and executing controlled temperatureunits programs for manufacturing and/or laboratory operations.
- Experienceinteracting with regulatory agencies
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
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Company Trade Name: Merck