Senior Engineer - Formulation, Laboratory & Experimentation

Job Description

This Senior Engineer position will provide engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for non-sterile operations and clinical packaging 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, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.

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 Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM).

Provide engineering and quality engineering (QE) support, ensuring facilities, 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, 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 engineering and maintenance groups, as well as outside vendor support.  Support is inclusive of both ongoing operations and installation of new capital/facility improvements.

Provide facility engineering support, capital project administration (processing capital requests and administering capital project closeout activities) to support timely spending per approved spend plans.  Areas supported will primarily include FLEx OSD, with a secondary focus on RY119 and miscellaneous GMP Drug Product areas in Rahway.  Additional responsibilities include capital project execution, placing capital purchase orders and developing standard work guides for capital project transactions.  A secondary area of focus will be supporting the mechanical aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, managing budgets, asset depreciation, and coordinating mechanical work performed by maintenance personnel, contractors/vendors, and facility operating staff.

Education Minimum Requirement: 

• Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related Drug Product/OSD experience and/or relevant manufacturing/engineering 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 to the work across both Quality and Facility aspects to support the business.  

• Effective organizational skills. 

• Effective communication

• Strong computer skills

Preferred Experience and Skills: 

• Maintenance & Engineering techniques and management and Capital Project management. 

• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)

• eVal  - 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.

NOTICE FOR INTERNA