Associate Specialist - Equipment Design and Facilities Engineering (Onsite)

Job Description

Role Summary:

The Chemical Engineering Research & Development department is seeking an engineering associate specialist for the Equipment Development Facilities Engineering team to primarily act as a maintenance team member supporting the API Development facilities, including but not limited to the 800 Prep Lab, as well as potent development labs in Bldg. 800, 818, and 80R. These are potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing facilities located in Rahway, New Jersey. Responsibilities include day-to-day support of lab facility and equipment therein, including reliability, operability/maintainability, and execution of capital and expense projects to enhance facility compliance, new processing technologies, and production capacity.

Key Functions:

• Maintain lab and utility equipment by developing and executing maintenance strategies,
• Perform day-to-day technical oversight of both internal and 3rd party maintenance teams,
• Work with lab process teams to support planning, scheduling and execution of routine corrective/preventive maintenance and facility annual shutdown activities,
• Demonstrate a strong Compliance mindset through application of learned knowledge of cGMP and Safety requirements,

• Support asset compliance, status and disposition via use of computerized maintenance software,
• 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/process setups with line of Sight to the Pilot Plants,
• Leverage learned knowledge to support equipment troubleshooting efforts,

• As part of a team, execute equipment reliability initiatives, facility improvement projects, and new technology implementation in support of development pipeline programs (typ. range of $10K to <$1MM scale), and
• Support and build skills for incident root cause analysis, including documentation, reporting, and action item management.

Education and Experience Minimum Requirements:

• BS in Engineering with 1+ years of experience in Facility Maintenance and/or Project Management

Required Experience and Skills:

• Strong mechanical aptitude,
• Demonstratable 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 and in some cases lead problem-solving efforts, and
• Fluent in Microsoft Office, use of email and meeting facilitation

Desired Experience and Skills:

• Knowledge of Change Management processes and principles,
• Experience interacting with skilled trades (Piping, Electrical, Millwrights, Instrumentation, 3rd party contractors and vendors),
• Maintenance experience in GMP environments, including familiarity with US and EU Safety and GMP compliance regulations,
• Experience operating/maintaining lab scale equipment,
• Ability to read and understand P&IDs,
• Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities,
• Trained in use of 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, Div I and II),
• Experience working in a facility governed by Standard Operating Procedures (SOP) and/or cGMP documents, and
• Experience with high-risk work including, but not limited to, Lockout/Tagout, Hazardous Energy Control, Elevated Work, and Confined Space Entry

#PRD

#eligibleforERP

Required Skills:

Adaptability, Data Analysis, Engineering Standards, Equipment Installations, Equipment Maintenance, Equipment Set Up, Evaluate Information, Facility Engineering, Operation Maintenance, Safety Measures, Shutdown Management, Team Communication, Teamwork, Technical Problem-Solving

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

…