Associate Director, Equipment Development and Facility Engineering Technology Engineer

Merck • Rahway, NJ

1d • Hybrid

About The Position

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that requires a high degree of process, mechanical and engineering knowledge. The Equipment Development and Facility Engineering (EDFE) Technology Engineer position will report to the Associate Director, Engineering and will be a member of the Modality Agnostic Chemistry Scaleup (MACS) EF Team at the Rahway, NJ facility. Enabling Facilities is responsible for the development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. EDFE's role within EF includes design, installation, qualification, startup, maintenance and troubleshooting of internal pilot plant equipment and the associated facility systems. The Associate Director, EDFE Technology Engineer role will serve as a team member supporting our company's API Pilot Facilities including the Small Scale Organics (SSO) Pilot Plant, Preparatory (Kilo) Labs, Unit Operations (UOps) Lab, the Hazardous Reaction Lab (HRL), and the new Modality Agnostic Chemistry Scaleup (MACS) Center. MACS is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance process development and GMP clinical manufacturing plant currently being constructed in Rahway, New Jersey. The Associate Director will serve as a valued team member during the MACS Center Execution and Startup Phases and will continue to support the facility’s operations after start-up. While MACS is currently under construction, the selected candidate will contribute to equipment design, system commissioning/qualification, and operational readiness planning to enable facility startup. Long-term, the selected candidate will lead ongoing assessments and development of emerging or novel value-added technologies to support upcoming programs and to maintain relevance of the capabilities in each API facility previously listed. The candidate will regularly network with various chemists, engineers and program leaders from partner organizations to identify external needs as well as facility engineers, operations specialists, compliance representatives, and other EF team members. A successful candidate will leverage these connections to stay well attuned to the status of current and planned research activities in a very dynamic environment, demonstrating curiosity and passion for scouting, assessing, and facilitating installation of new process technologies which ultimately will contribute to the flexibility of the MACS facility and the speed and robustness of the Company's pipeline.

Requirements

• Bachelor of Science degree in an Engineering or related scientific field with minimum of 10 years relevant experience, or a Master’s degree with 9 years of relevant experience, or a PhD degree with 6 years of relevant experience
• A strong process and mechanical aptitude with the ability to read and understand P&IDs and technical/mechanical diagrams
• Desire to have regular hands-on presence on the plant/shop floor
• Process scale-up experience from laboratory to pilot plant and/or pilot plant to commercial
• Experience in pilot-plant scale process equipment, instrument, and automation design
• Familiarity with US and EU Safety and GMP compliance regulations
• Experience with GMP facility design, equipment start-up and/or qualification
• Experience with Electrical Classifications for solvent and dust (Class I and II, Div I and II) and understanding of its impact on equipment design
• Track record of establishing productive working relationships with process development scientists, operators, and external vendors
• Excellent organizational skills with an ability to multi-task
• Effective interpersonal and communication skills, both verbal and written
• A collaborative mindset
• Desire and willingness to learn, contribute and lead
• Track-record of independent problem-solving

Nice To Haves

• Experience operating/maintaining pilot scale or prep lab scale equipment
• Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities
• Familiarity with Change Management processes and principles
• Experience with preparing Standard Operating Procedures (SOP) and cGMP documents
• History interacting with skilled trades (Piping, Electrical, Millwrights, Instrumentation, 3rd party contractors and vendors).

Responsibilities

• Networking with partner groups including Project Teams, Enabling Technologies, Manufacturing Division groups, Quality, Safety and Commercial facilities to scout emerging technologies to enable the pipeline
• Partnering with chemists and engineers to develop the business case for new technology investments
• Assessment of pilot plant equipment and infrastructure capabilities to ensure sufficient capacity to support anticipated program needs
• Performing early assessments of proposed new technologies to identify feasibility
• Developing proposals for capital or expense projects to meet the defined needs
• Defining process, mechanical, electrical, safety and instrumentation requirements
• Performing assessments of vendor offerings
• Providing technical oversight to internal/external construction efforts
• Prototyping and initial demonstration planning and execution
• Coordinating commissioning, qualification, and characterization for new equipment and technologies to be used for GMP manufacture
• Socializing technology initiatives through internal and external presentations and publications
• Engaging with partner organizations for successful scale-up to commercialization

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees