Associate Engineer - Commissioning, Qualification, Validation; CQV

The Associate Engineer will provide engineering, commissioning / qualification / validation (CQV), and quality engineering support for the Rahway FLEx (Formulation, Laboratory & Experimentation) center located in Rahway, NJ. The FLEx facility supports formulation, filling, and packaging of non-sterile Oral Solid Dosage (OSD) and Inhalation products for clinical, stability, development and critical program needs (process development, scale-up, launch/transfer, and process optimization).

The role supports timely delivery of clinical supplies and development batches by maintaining equipment, facilities, utilities, and computer systems in accordance with cGMP, safety requirements, and Reliability Maintenance best practices. The position requires regular interaction with partner groups (Facilities Management, OEMs, vendors) and collaboration with business areas to sustain manufacturing operations. The FLEx Center operates two shifts; this role requires second-shift availability and on-call support as needed.

• Provide engineering and quality engineering support for facilities, utilities and equipment to be suitable for GMP and developmental use.
• Troubleshoot equipment (mechanical/electrical/automation), drive operational improvements, and contribute to protocol development.
• Participate in and support continuous improvement activities within the non-sterile modality to expand equipment and operational efficiencies.
• Develop, author, execute, and maintain CQV documentation (commissioning, qualification, validation protocols, reports, Validation Master Plans, Project Execution Plans, schedules)
• Perform commissioning, qualification, decommissioning, and periodic review activities for equipment, systems and critical utilities.
• Support installation of new capital/facility improvements and provide capital project support for small and large multidisciplinary projects.
• Maintain GMP documentation (e.g., GMP engineering drawings, equipment database tracking) and ensure Good Documentation Practices.
• Participate in Quality Notifications (QN), investigations, root cause analysis, CAPA development and implementation, FMEAs, PHAs and other risk assessments.
• Support internal and external audits and regulatory inspections; provide timely, accurate responses to observations/questions.
• Facilitate equipment/system changes, support QMS activities, and execute business-aligned periodic reviews.

• Bachelor's degree in Mechanical or Chemical Engineering

• Minimum 1 years related pharmaceutical experience or relevant internship experience.
• Experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDocP), and GMP pharmaceutical manufacturing plant operations.
• Knowledge of commissioning and qualification/validation processes, including periodic review.
• Familiarity with Quality, cGMP, Safety, and Environmental policies and procedures.
• Troubleshooting skills (mechanical, electrical, automation) and experience supporting capital projects.
• Ability to flexibly prioritize and adapt work across both Quality and Facilities aspects.
• Strong organizational, verbal and written communication skills.
• Strong computer literacy and ability to use standard business software.

• Experience with CMMS (Pro Cal) and CCMS (e.g., SAP Plant Maintenance, computerized calibration/maintenance systems), Kneat or other paperless electronic validation systems (eVal)
• Experience with pharmaceutical processing equipment and utility systems (OSD equipment such as tablet compression, encapsulation, spray drying, film coating, isolators; compressed gas systems and purified water systems).
• Familiarity with planning and scheduling practices and business/financial processes.
• Experience with Lean, Six Sigma, continuous improvement initiatives, RCA, FMEAs, and PHAs.
• Demonstrated ability to work independently and to lead or facilitate tasks and small projects.
• Working knowledge of regulatory requirements relevant to GMP manufacturing facilities and equipment.

• Calibration Management Software, GMP Guidelines, CMMS, Equipment Commissioning, Equipment Qualification, Equipment Validation, Good Documentation Practices, Process Engineering, Troubleshooting, CQV, Reliability Maintenance.

Chemical Engineering, Computerized Maintenance Management Systems (CMMS), Equipment Commissioning, Equipment Qualification, Equipment Set Up, Equipment Validations, Good Documentation…