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 laboratories in Buildings 800, 818, and 80R. These facilities support potent, multi-modality drug substance development and GMP clinical manufacturing in Rahway, New Jersey. The position provides day-to-day support for laboratory facilities and equipment, with a focus on reliability, operability, maintainability, and projects that enhance compliance, introduce processing technologies, or increase production capacity. The role supports routine and preventive maintenance, shutdown activities, equipment compliance and qualification, troubleshooting, reliability initiatives, facility improvements, and implementation of new technologies. It also contributes to incident root cause analysis and works with internal and third-party maintenance teams, process teams, and Quality groups.

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 with Microsoft Office, email, and meeting facilitation.

Nice To Haves

  • Knowledge of change management processes and principles.
  • Experience interacting with skilled trades, including piping, electrical, millwrights, instrumentation, third-party contractors, and vendors.
  • Maintenance experience in GMP environments, including familiarity with US 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 with clean room 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 compliant work.
  • Support asset compliance, status, and disposition using computerized maintenance software.
  • Interact with Quality groups to support audits, qualify equipment, and maintain readiness for GMP work.
  • Develop expertise to ensure effective, safe, and compliant equipment and process setups, with a 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 implementations supporting development pipeline programs, typically ranging from $10,000 to less than $1 million.
  • Support and build skills in incident root cause analysis, including documentation, reporting, and action-item management.

Benefits

  • Medical, dental, and vision healthcare benefits.
  • Other insurance benefits for employees and families.
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, compassionate days, and sick days.
  • Eligible for an annual bonus and long-term incentive, if applicable.
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