Specialist, Engineering; Onsite

Non-Sterile Specialist, Engineering

Position Summary:

This engineer provides on‑site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non‑sterile operations within our company’s Research Labs and Pharmaceutical Sciences groups. Work is performed on the second shift, Monday through Friday. The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products, including process development, scale‑up, launch, transfer, and optimization for commercial products.

• Maintain facility, utilities, and manufacturing equipment in compliance with GMP and safety requirements while applying reliability maintenance best practices.
• Support equipment validation from commissioning through decommissioning; manage changes and periodic reviews.
• Investigate deviations, issue quality notifications, identify root causes, and develop CAPAs.
• Maintain GMP documentation and support clinical operations.
• Manage purchase orders, capital requests, and coordinate installation and commissioning of new equipment.
• Provide engineering and compliance support for non‑sterile process equipment and utilities, and act as a subject‑matter expert during regulatory interactions.
• Operate with minimal supervision and serve as a technical and compliance resource during second‑shift operations.

Bachelor’s degree in engineering plus a minimum of 2 years of related experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats.

• Strong familiarity with quality, cGMP, safety, and environmental policies and procedures.
• Familiarity with oral solid dosage drug‑product manufacturing equipment and processes.
• Experience with computerized maintenance and management systems (CMMS).
• Strong mechanical, electrical, and automation troubleshooting ability.
• Ability to flexibly adapt to workflow across quality and facility aspects.
• Effective organizational, communication, and technical writing skills.
• Strong computer skills.

• Maintenance and engineering techniques and management, including capital project management.
• Independent problem‑solving capabilities.
• Experience with SAP Plant Maintenance (gatekeeping and work‑order prioritization).
• Experience with eVal/Kneat paperless electronic validation system.
• Experience with Pro Cal as a computerized calibration maintenance system (CCMS).
• Familiarity with planning and scheduling practices and business/financial practices.

• Adaptability and biopharmaceuticals knowledge.
• cGMP guidelines, electronic batch records, GMP compliance.
• Laboratory experiments, mammalian cell culture.
• Pharmaceutical biology, manufacturing, sciences, pharmacodynamics,
  pharmacotherapeutics
  .
• Process optimization, product formulation, SOP writing.

Salary range: $87,300.00 – $. Eligible for annual bonus and long‑term incentive, if applicable.

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

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.