Facility Engineer, MACS Senior Specialist (On-site)
Merck
Summary
The Enabling Facilities group within the Chemical Engineering Research & Development Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical, mechanical, and project management responsibility. The Facility Engineer position will report to the Associate Director, Engineering and will be a member of the Equipment Development and Facility Engineering team.
Job description
Responsibilities
This role at the Sr. Specialist level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup Center, a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently under construction.
- Support construction close-out, equipment and facility commissioning/qualification, and operations readiness activity workstreams
- Foster a culture of collaboration, learning and innovation within Enabling Facilities and the MACS Capital Project and Operations
- Collaborate with Enabling Facilities and MACS Operations team members, development engineers & chemists, and compliance representatives to ensure quality and safe delivery of clinical supplies
- Ensure availability and reliability of facilities and scientific rigor of processes
- Support new and/or existing facilities across the Small Molecule Process Research & Development network and Enabling Facilities capital projects as required
Additional Supported Areas
Small Scale Organics Pilot Plant (SSO): a GMP manufacturing facility serving as the Process Research and Development internal node for small molecule drug substance clinical manufacture and preferred site for first pilot of commercial small molecule processes. Prep Lab Area: generates data contributing to process definition and provides Phase I/IIa clinical material, with kilo scale capability establishing reaction parameters and supporting pipeline programs such as ADCs, PDCs, and other cross modality compounds.
Requirements
- Bachelor of Science degree in an Engineering or related scientific field with minimum of 6 years relevant experience, or Master's degree with 5 years of relevant experience, or 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, Div 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/maintaining manufacturing, pilot scale or prep lab scale equipment
- Experience in supporting compliance investigations and change management
- Familiarity with US and EU 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
- Fluent in Microsoft Office, use of email, and meeting facilitation
- Effective interpersonal and communication skills, both verbal and written
- Sound decision-making skills, knowing when to escalate vs. taking action, and ability to explain rationale for decisions
- Excellent organizational skills to multi-task
- Desire and willingness to learn, contribute and lead
- Track-record of independent problem-solving
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.