Job Description
This position will be responsible for providing engineering leadership and cross-functional project support at the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center. Areas supported include Oral Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).
The FLEx facility (inclusive of RY119) supports the formulation and filling of clinical, stability, and developmental Sterile, OSD and Inhalation supplies. These facilities support 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 the Rahway based clinical equipment, systems and facilities 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 project/initiative leadership, collaboration and routine interaction with Partner Groups such as Global Engineering Services (GES), Global Workplace & Enterprise Services (GWES), Global Safety and the Environment (GSE), Procurement and Original Equipment Manufacturers (OEM) and vendors. The engineer in this position will support coaching and mentoring of engineers within the group.
Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained and are suitable for both GMP and developmental use. Support the authoring, review, and/or approval of equipment specifications and GMP procedures and documentation, with an emphasis on process equipment and critical utilities. Support the preparation and approval of qualification protocols and summary reports. Support new equipment receipt, testing, and commissioning. Maintain GMP documentation where applicable, such as GMP engineering drawings, equipment database tracking, and Key Performance Indicator (KPI) data. Lead, facilitate and/or participate in investigations, and any related corrective action/preventive action (CAPA).
Additional responsibilities include supporting the engineering and maintenance aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, and coordinating mechanical work performed by maintenance personnel, contractors/vendors, and facility operating staff. The team will contribute to design input, specification development, and hands-on troubleshooting to ensure process equipment (manufacturing and packaging) and utilities remain functional and available to meet schedule demands.
Education Minimum Requirement:
Bachelor’s degree in engineering or science plus a minimum of 7 years of related manufacturing operations or engineering support experience.
Required Experience and Skills:
Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
Familiarity with Computerized Maintenance and Management Systems (CMMS).
Reliability-based engineering experience and Troubleshooting ability (mechanical/electrical/automation).
Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.
Strong project leadership skills.
Strong organizational skills.
Effective communication.
Strong computer skills.
Preferred Experience and Skills:
Managerial, team and/or supervisory experience.
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). Fluency in ProCal.
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.
Employee Status: Regular
Relocation: No
VISA Sponsorship: No
Travel Requirements: 10%
Shift: 1st - Day
Job Posting End Date: 10/9/2024
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