Sterile Engineer, Specialist (On-site)

Job Description

Job Description

This Engineer position will provide on-site engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, for sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Pharm Ops Engineering is responsible for providing technical support across quality engineering, equipment reliability and maintenance, and sterilization and cleaning validation to ensure safe, compliant, and reliable operations.

The FLEx facility supports the formulation and aseptic filling of clinical, stability, and developmental sterile products, including key programs advancing through process development, scale-up, launch, technology transfer, and commercial process optimization.

This position primarily supports the FLEx Sterile 2 manufacturing area, with secondary support responsibilities for FLEx Sterile1. FLEx Sterile1 is currently operational, while FLEx Sterile2 is under construction as part of a major capital project, with a target Ready-for-Science date of Q1 2030. This position is primarily intended for 1st shift, but batch activity may necessitate some off-shift support.

The incumbent provides engineering support for Quality Engineering (QE), capital projects, equipment reliability, and sterile validation programs supporting the FLEx Sterile manufacturing facilities. This role partners closely with Operations, Quality, Engineering, Maintenance, Global Engineering Services (GES), Facilities Management (FM/GWES), OEMs, and external vendors to support ongoing operations, facility upgrades, and the installation, commissioning, qualification, and lifecycle management of manufacturing equipment and utility systems.

Key responsibilities include supporting the full equipment lifecycle from commissioning through decommissioning; authoring, executing, reviewing, and approving qualification and validation documentation; managing equipment and system changes; conducting periodic reviews; supporting investigations, deviations, Quality Notifications (QNs), and CAPAs; and maintaining GMP engineering documentation and asset records. The role applies reliability-centered maintenance principles to ensure equipment availability and support the timely manufacture of clinical, stability, and developmental products.

The position also serves as a Subject Matter Expert (SME) for sterilization and cleaning validation programs. Responsibilities include developing and maintaining validation strategies, SOPs, protocols, and reports; performing technical assessments; coordinating validation activities with third-party service providers; troubleshooting technical issues; and ensuring compliance with GMP, safety, and regulatory requirements.

Additional responsibilities include contractor and vendor oversight, work order governance, purchase order and budget support, asset management, capital project administration, equipment startup activities, and regulatory inspection support. Success in this role requires strong technical expertise, cross-functional collaboration, problem-solving skills, and the ability to support both operational and project-based objectives within a regulated pharmaceutical manufacturing environment.

Education Minimum Requirement:

• Bachelor's degree in engineering or science plus a minimum of 2 years of related Drug Product/Sterile/Validation experience.

Required Experience and Skills:

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Sterile Drug Product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Troubleshooting ability (mechanical/electrical/automation)
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.
• Effective organizational skills.
• Effective communication and technical writing skills.
• Strong computer skills

Preferred Experience and Skills:

• Maintenance & Engineering techniques and management and Capital Project management.
• Independent problem- solving.
• SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
• eVal/Kneat - Paperless electronic validation system
• Experience with ProCal 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.

EligibleforERP

Required Skills:

Capital Project Management, cGMP Guidelines, Cleaning Validations, Clinical Manufacturing, Engineering Support, Equipment Management, Maintenance Management Systems, Pharmaceutical Sciences, Pilot Plant Operations, Quality Engineering, Regulatory Requirements, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

Preferred Skills:

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