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Merck

Makes medicines, vaccines and animal treatments

Facility Engineer – MACS Senior Specialist

Bioprocess & BiomanufacturingPosted on Nov 12
Full-timeRahway, NJ, USA

About the Job

Requirements

  • A Bachelor of Science degree in an Engineering or related scientific field with a minimum of 6 years of relevant experience, or a Master's degree with 5 years of relevant experience, or a PhD degree with 2 years of relevant experience.
  • Experience with Good Manufacturing Practice facility design and equipment start-up and/or qualification.
  • Strong mechanical aptitude.
  • Ability to read and understand P&IDs.
  • Familiarity with Electrical Classifications for solvent and dust (Class I and II, Division I and II).
  • Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
  • Experience interacting with skilled mechanical tradesmen and construction management organizations.
  • Experience operating or maintaining manufacturing, pilot-scale, or prep-lab-scale equipment.
  • Experience supporting compliance investigations and change management.
  • Familiarity with United States and European Union Good Manufacturing Practice and safety compliance regulations.
  • Familiarity with Change Management processes and principles.
  • Ability to comprehend and/or prepare Standard Operating Procedures and Good Manufacturing Practice documents.
  • Fluency in Microsoft Office, email use, and meeting facilitation.
  • Effective verbal and written interpersonal and communication skills.
  • Sound decision-making skills, including knowing when to escalate versus taking action and explaining the rationale for decisions.
  • Organizational skills to multitask.
  • Desire and willingness to learn, contribute, and lead.
  • Track record of independent problem-solving.

Responsibilities

  • Serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup Center.
  • Support construction close-out, equipment and facility commissioning and qualification, and other critical operations-readiness workstreams to complete the capital project.
  • Foster collaboration, learning, and innovation within Enabling Facilities, the Modality Agnostic Chemistry Scaleup Capital Project, and Modality Agnostic Chemistry Scaleup Operations.
  • After facility startup, collaborate with Enabling Facilities and Modality Agnostic Chemistry Scaleup Operations team members, development engineers and chemists, and compliance representatives to ensure quality and safe delivery of clinical supplies, facility availability and reliability, scientific rigor of processes, and flexibility and speed in the company pipeline.
  • Support new and/or existing facilities across the Small Molecule Process Research & Development network and Enabling Facilities capital projects as required.

Desired Qualifications

  • Experience in capital projects, specifically as the end user.
  • Experience providing technical mentorship.
  • Experience with potent compound processing and containment systems.
  • Experience interacting with or overseeing management of process utility systems associated with a large drug substance pilot plant, including WFI generation and distribution, process chillers, and vacuum systems.
  • Experience coordinating maintenance activities around processing activities to support reliable facility operation.
  • Experience with Process Analytical Technology.
  • Experience developing new instrumentation technologies.
  • Training in use of Hexagon for Plant Maintenance management and SAP for financial transactions.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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