Associate Engineer - Commissioning, Qualification, Validation (CQV)

MSD Malaysia; Rahway, Northern (NJ, KY); Hybrid; USD 72,000 - 113,000; Full time

Job summary

MSD Malaysia, Rahway facility, seeks an Associate Engineer to support engineering, CQV, and quality activities for GMP-compliant processes in a two-shift environment. You will assist in commissioning, qualification, validation, and documentation, coordinating with Facilities, QA, and external partners.

The role emphasizes equipment and process improvements, CAD/GMP documentation, and timely responses to audits and observations, enabling development and manufacturing operations.

Qualifications

• Requires a Bachelor’s degree in Mechanical or Chemical Engineering and pharmaceutical industry exposure.
• Experience with cGMP/GDocP and GMP plant operations is preferred.
• Strong communication, documentation and problem-solving abilities are essential.

Responsibilities

• Provide engineering and quality engineering support for facilities, utilities and equipment to be suitable for GMP and developmental use.
• Troubleshoot equipment and drive operational improvements; develop CQV documentation (protocols, reports, Master Plans).
• Support commissioning, qualification, validation, and periodic reviews for equipment and systems; participate in audits and CAPA.0
• Assist in capital projects and regulatory inspections; maintain GMP documents and QMS activities.

Skills

Troubleshooting (mechanical/electrical

CQV knowledge

GMP knowledge

Quality engineering

Project coordination

Education

Bachelor’s degree in Mechanical or Chemical Engineering

Tools

CMMS (ProCal)

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.

EligibleforERP 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

Preferred Skills

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. 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: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts.

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

Salary & Benefits

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.

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

Company Information

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.