About The Position

The Chemical Engineering Research & Development department is seeking an engineering associate specialist for the Equipment Development Facilities Engineering team. The role primarily supports maintenance of API Development facilities, including the 800 Prep Lab and potent development labs in Buildings 800, 818, and 80R. These facilities support potent, multimodality drug-substance development and GMP clinical manufacturing, including small molecules, macrocyclic peptides, and bioconjugates, and are located in Rahway, New Jersey. The position provides day-to-day support for laboratory facilities and equipment, with a focus on reliability, operability, maintainability, and executing capital and expense projects that improve compliance, introduce processing technologies, and increase production capacity. The specialist develops and executes maintenance strategies, provides technical oversight of internal and third-party maintenance teams, and works with laboratory process teams to plan and carry out routine corrective and preventive maintenance and annual facility shutdowns. The role supports asset compliance, equipment qualification and audit readiness, troubleshooting, equipment reliability initiatives, facility improvement projects, and implementation of new technologies. It also contributes to incident root cause analysis and related documentation and action-item management. The position is onsite and involves work within a laboratory where hazardous materials are present. The role requires 10% travel. Relocation is domestic; visa sponsorship is not available. The employee status is regular.

Requirements

  • Bachelor of Science in Engineering.
  • At least 1 year of experience in facility maintenance and/or project management.
  • Strong mechanical aptitude.
  • Demonstrable knowledge of facilities and equipment from an operations and maintenance perspective.
  • Familiarity with process flow diagrams and/or mechanical drawings.
  • Effective communication and collaboration skills.
  • Ability to gather data, evaluate potential options, and make recommendations to support decision-making.
  • Ability to learn, contribute to, and in some cases lead problem-solving efforts.
  • Fluency in Microsoft Office, email use, and meeting facilitation.

Nice To Haves

  • Knowledge of change management processes and principles.
  • Experience interacting with skilled trades, including piping, electrical, millwright, and instrumentation workers, as well as third-party contractors and vendors.
  • Maintenance experience in GMP environments, including familiarity with U.S. and EU safety and GMP compliance regulations.
  • Experience operating or maintaining laboratory-scale equipment.
  • Ability to read and understand P&IDs.
  • Experience with potent compound processing and containment systems, such as isolators, or cleanroom facilities.
  • Training in Hexagon EAM for plant maintenance and SAP for financial business systems management.
  • Experience with Process Analytical Technology (PAT).
  • Familiarity with electrical classifications for solvent and dust (Class I and II, Division I and II).
  • Experience working in a facility governed by Standard Operating Procedures (SOPs) and/or cGMP documents.
  • Experience with high-risk work, including Lockout/Tagout, Hazardous Energy Control, elevated work, and confined space entry.

Responsibilities

  • Maintain laboratory and utility equipment by developing and executing maintenance strategies.
  • Provide day-to-day technical oversight of internal and third-party maintenance teams.
  • Work with laboratory process teams to plan, schedule, and execute routine corrective and preventive maintenance and annual facility shutdown activities.
  • Apply knowledge of cGMP and safety requirements to support compliance.
  • Use computerized maintenance software to support asset compliance, status, and disposition.
  • Interact with Quality groups to support audits, qualify equipment, and maintain readiness to perform GMP work.
  • Build expertise to ensure effective, safe, and compliant equipment and process setups, with line of sight to the Pilot Plants.
  • Use learned knowledge to support equipment troubleshooting.
  • As part of a team, execute equipment reliability initiatives, facility improvement projects, and new technology implementation in support of development pipeline programs, typically ranging from $10,000 to under $1 million.
  • Support and build skills in incident root cause analysis, including documentation, reporting, and action-item management.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Other insurance benefits for employees and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate days
  • Sick days
  • Annual bonus eligibility
  • Long-term incentive eligibility, if applicable
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