Associate Engineer - Commissioning, Qualification, Validation (CQV)

Merck; New Jersey; On-site; USD 75,000 - 115,000; Full time

Job summary

Merck in Rahway, NJ, seeks an Associate Engineer to support engineering, CQV, and quality activities for the FLEx center, ensuring GMP-compliant operation of facilities, utilities, and equipment.

You will troubleshoot mechanical, electrical, and automation systems, drive improvements, and support CQV documentation across development and scale-up projects in a two-shift facility.

Qualifications

• Minimum 1 year related pharmaceutical experience or internship.
• Experience with cGMP, GDocP, and GMP pharmaceutical manufacturing plant operations.
• Knowledge of commissioning and qualification/validation processes.
• 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.

Responsibilities

• 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).
• 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.

Skills

Verbal communication

Written communication

Organization

Troubleshooting

Education

Bachelor's degree in Mechanical or Chemical Engineering

Tools

CMMS ProCal

CCMS SAP Plant Maintenance

Kneat

eVal

Job description

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.

Primary Responsibilities

• 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.

Required Education

Bachelor's degree in Mechanical or Chemical Engineering.

Required Experience

• 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.

Preferred Experience and Skills

• Experience with CMMS (ProCal) 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.

Key skills / Keywords

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

Required Skills

Chemical Engineering, Computerized Maintenance Management Systems (CMMS), Equipment Commissioning, Equipment Qualification, Equipment Set Up, Equipment Validations, Good Documentation Practices, Good Manufacturing Practices (GMP), Mechanical Engineering, Pharmaceutical Manufacturing, Writing Technical Documents.

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.