Associate Specialist, Engineering (Onsite)

Associate Specialist, Engineering (Onsite) Merck - 4.1 Rahway, NJ Job Details Full-time $71,900 - $113,200 a year 1 day ago Benefits Paid holidays Health insurance Dental insurance 401(k) Vision insurance Qualifications Quality control corrective actions Regulatory inspections Bachelor's degree in mechanical engineering Computer operation Chemical Engineering Pharmaceutical regulatory compliance Computer literacy SAP Engineering Equipment installation Mechanical Engineering Compliance audits & assessments Six Sigma methodology implementation Engineering process optimization Environmental compliance Corrective and preventive actions (CAPA) GMP Mid-level Industrial equipment troubleshooting CMMS Manufacturing facility Electrical experience Bachelor's degree in engineering Bachelor's degree Quality control documentation Continuous improvement Pharmaceutical plant experience Electrical troubleshooting Bachelor's degree in chemical engineering Quality standards in production Computer skills FMEA Manufacturing maintenance Quality audits 1 year Commissioning phase involvement Root cause analysis OEM Communication skills Implementing lean manufacturing processes Process engineering Facilities maintenance Mechanical troubleshooting Chemical engineering Project scheduling Regulatory compliance management Engineering validation Full 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 by Spring 2026 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 #PSCS FLEx2026

Required Skills:

Capital Projects, Capital Projects, Computer Literacy, Contractor Oversight, Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Equipment Troubleshooting, Estimation and Planning, GMP Compliance, GMP Validation, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Pharmaceutical Processing, Process Control, Process Engineering, Process Optimization, Process Scale Up, Production Process Development, Protocol Development, Quality Engineering, SAP Plant Maintenance (PM), Tablet Manufacturing {+ 1 more}

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. Please click here if you need an accommodation during the application or hiring process. 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 U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". 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 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 Search Firm Representatives Please Read Carefully 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.

Employee Status:

Regular Relocation:

No relocation

VISA Sponsorship:

No Travel Requirements:

No Travel Required Flexible Work Arrangements:

Not Applicable Shift:

1st - Day, 2nd -

Evening Valid Driving License:

No Hazardous Material(s): n/a

Job Posting End Date:

05/2/2026 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.

Requisition ID:

R395579