Associate Specialist, Engineering

Overview

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). Off-shift (2nd shift) Monday to Friday work is required to meet the operational needs.

• Maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements, applying Reliability Maintenance best practices to ensure timely availability of clinical and development batches.
• Provide support for Quality Engineering (QE) and capital projects; interface with site engineering and maintenance groups and external vendors to support ongoing operations, upgrades, and installation of new capital equipment.
• Support the full equipment validation lifecycle (from commissioning through decommissioning) by preparing, executing, and approving protocols; manage equipment/system changes and perform periodic reviews.
• Evaluate deviations, issue Quality Notifications (QN), perform investigations, identify root causes, and implement corrective actions/preventive actions (CAPA); maintain GMP documentation such as GMP engineering drawings and equipment database tracking.
• Support mechanical aspects of clinical operations; coordinate activities by maintenance personnel and contractors/vendors; gatekeep work orders; manage purchase orders and budgets; support capital project administration including processing capital requests and project close-out activities.
• Coordinate installation, upgrades, and commissioning of new capital equipment; serve as a Subject Matter Expert (SME) on validation of equipment used for sterilization and cleaning in clinical drug product manufacturing.
• Support regulatory interactions as needed and participate in sterile validation programs, including sterilization and cleaning validations with third-party/vendor support; own, author, and/or review validation SOPs, protocols, and summary reports.
• Address issues from conceptual to approval and ensure alignment of equipment and instruments for field execution.

• Bachelor s degree in engineering or science. Prior experience is not required, however exposure to drug product manufacturing, sterile operations, or validation through internship or co-op experience is preferred.

• 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.

• 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 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.

• Contractor Oversight, Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Estimation and Planning, GMP Compliance, GMP Validation, Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Process Control, Process Optimization, Process Scale Up, Teamwork, Writing Technical Documents

Other items such as current employee/contingent worker applications, or non-job-specific boilerplate content have been removed for clarity. The role details including shift, travel, and eligibility information are retained from the original posting where appropriate.

• Shift: 2nd - Evening
• Relocation:
  Domestic
• VISA Sponsorship:
  No
• Travel Requirements: 10%
• Job Posting End Date: