Associate Engineer - Commissioning, Qualification, Validation (CQV)

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.

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The salary range for this role is

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 at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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