Associate Engineer - Commissioning, Qualification, Validation (CQV)

Merck; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck in Rahway, NJ, seeks an Associate Engineer to support CQV, engineering and quality activities for the Rahway FLEx center. You will help maintain facilities, utilities and equipment to GMP standards while engaging with facilities, OEMs and vendors.

This role operates on a second shift with on-call support. Responsibilities include troubleshooting, protocol development, CAPA, QN investigations and audits coordination, ensuring timely delivery of clinical supplies and development batches.

Qualifications

• Bachelor’s degree required in Mechanical or Chemical Engineering.
• Minimum 1 year related pharmaceutical experience or internship.
• Experience with cGMP, GDocP, and GMP pharmaceutical manufacturing.
• Knowledge of commissioning and qualification/validation processes, including periodic review.
• Familiarity with Quality, cGMP, Safety and Environmental policies.
• Troubleshooting skills across mechanical/electrical/automation domains.

Responsibilities

• Provide engineering and quality engineering support for facilities, utilities and equipment to be GMP-ready.
• Troubleshoot equipment and drive operational improvements; participate in protocol development.
• Support continuous improvement within non-sterile modality to expand equipment and operations.
• Develop, execute and maintain CQV documentation and schedules.
• Perform commissioning, qualification, decommissioning and periodic reviews for equipment and systems.
• Support installation of capital improvements and provide project support for small and large initiatives.
• Maintain GMP documentation and ensure Good Documentation Practices.

Skills

Chemical Engineering

CMMS

Equipment Commissioning

Equipment Qualification

Equipment Set Up

Equipment Validations

Good Documentation Practices

GMP

Mechanical Engineering

Pharmaceutical Manufacturing

Writing Technical Documents

Education

Bachelor’s degree in Mechanical or Chemical Engineering

Tools

ProCal CMMS

CCMS (SAP Plant Maintenance)

Kneat

eVal

Job description

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

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/17/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The salary range for this role is $71,900.00 - $113,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available.