Senior Engineer, Pharmaceutical Operations Engineering

Job Description

This Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)

The FLEx sterile facility supports the formulation and filling of clinical and developmental supplies for sterile products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new capital build (FLEx Sterile2).

Primary responsibility will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require routine interaction with Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.

Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are maintained and are suitable for both GMP and developmental use.  Author, review and approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.  Prepare and approve qualification protocols and summary reports.  Execute qualifications, validation, commissioning, and decommissioning activities.  Prepare Validation plans and annual reports around critical equipment and systems.  Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database tracking.  Facilitate and/or participate in Quality Notification (QN) reporting, investigations, and any related corrective action/preventive action (CAPA).  Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.  Interface with site & global engineering and maintenance groups, as well as outside vendor support. 

Provide facility engineering support and capital project administration (processing capital requests and administering capital project closeout activities) to support timely spending per approved spend plans.  Areas supported include FLEx Sterile1, with operational readiness in 4Q2025, and a secondary focus on FLEx Sterile2, currently in project phase via GES.  Provide support of the mechanical aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, supporting budgets, asset depreciation, and coordinating mechanical work performed by maintenance personnel, contractors/vendors, and facility operating staff.

Off-shift (2nd shift) work will intermittently be expected as a part of the role to support operations areas.

Education Minimum Requirement: 

• Bachelor’s degree in engineering or science plus a minimum of 3 years of related Drug Product/sterile experience.

Required Experience and Skills: 

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

• Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). 

• Troubleshooting ability (mechanical/electrical/automation) and capital project (support). 

• 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. 

• Track-record of independent problem-solving

• SAP Training and skills - Project Manager (PM) role, 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. 

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