Associate Specialist, Operations (Onsite)

Merck & Co.-posted 3 months ago

$70,500 - $110,900/Yr

Full-time • Entry Level

Onsite • Rahway, NJ

Chemical Manufacturing

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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 provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure.

Support the Modality Agnostic Chemistry Scaleup (MACS) Center during construction and startup phase.
Contribute to equipment and facility design, equipment or material testing, system commissioning/qualification.
Establish procedures, documentation, and training necessary to operate and maintain a new business area after facility startup.
Collaborate closely with development engineers & chemists, compliance representatives, and other team members.
Perform equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution.
Handle a variety of reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations.
Support other areas such as Small Scale Organics Pilot Plant (SSO) and Prep Lab Area as required.

Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field plus one (1) year relevant work experience.
Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years experience.
High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing.
Effective interpersonal and communication skills, both verbal and written.
Excellent organizational skills to multi-task.
Desire and willingness to learn, contribute and lead.
Track-record of independent problem-solving.
Strong mechanical aptitude.
Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.

Experience working in a GMP clinical or manufacturing supply facility.
Experience with GMP facility design, equipment start-up and/or qualification.
Experience with small molecule drug substance and/or biologics process development.
Experience in supporting compliance investigations and change management.
Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents.
Experience operating/maintaining pilot scale or prep lab scale equipment.
Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
Experience with Potent Compound processing and containment systems.
Experience interacting with or overseeing the management of process utility systems.
Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
Operations experience in pilot plant or manufacturing environment.
Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations.
Lean Six Sigma Training/Certification.

Medical, dental, vision healthcare and other insurance benefits (for employee and family).
Retirement benefits, including 401(k).
Paid holidays, vacation, and compassionate and sick days.

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