Specialist, Engineering; Onsite

Job Description

This Engineer position will provide engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for non‑sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including critical program needs related to new products undergoing process development, scale‑up, launch, and transfer to the supply network and existing commercial products undergoing process optimization.

Primary responsibilities include maintaining all equipment in accordance with GMP and Safety requirements, exercising reliability‑maintenance best practices to ensure timely availability of clinical supplies and development batches, and collaborating with partner groups such as Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM). The engineer will provide engineering and quality engineering support, author and review GMP procedures and documentation (including Qualification/Validation plans and annual reports), and demonstrate knowledge of equipment operation to support troubleshooting, operational improvements, and protocol development.

The role involves preparing and executing qualifications, commissioning and decommissioning activities, maintaining GMP documentation (engineering drawings, equipment database tracking), facilitating Quality Notification reporting and CAPA, supporting internal audits and regulatory inspections, and providing capital‑project support for smaller and larger multidisciplinary projects. The FLEx Center operates on a two‑shift schedule and requires coverage beyond standard business hours.

• Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related Drug Product/OSD experience.

• Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity performing Root Cause Analysis and investigation.
• Troubleshooting ability (mechanical/electrical/automation) and capital project support.
• Ability to flexibly adapt to flow of work across both Quality and Facility aspects to support the business.
• Effective organizational skills.
• Effective communication.
• Strong computer skills.

• Engineering, maintenance & calibration experience of pharmaceutical processing equipment and utility systems.
• SAP Training and skills – Project Manager (PM) role, SAP Plant Maintenance.
• eVal – Paperless electronic validation system.
• Experience with Pro Cal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with Planning and Scheduling practices as well as business/financial practices.
• The candidate should be able to work independently and lead or facilitate tasks successfully.

• Adaptability, Capital Projects, cGMP Guidelines, Clinical Development, Cognitive Flexibility, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Personal Initiative, Pharmaceutical Process Engineering, Pharmaceutical Processing, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Protocol Development, Quality Management, Regulatory Inspections, Reliability Management, SAP Plant Maintenance (PM), SAP Support, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing.

• Current Employees apply HERE.
• Current Contingent Workers apply HERE.

We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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.

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