Specialist Engineering (Onsite)

Merck; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in Rahway, NJ is seeking an on-site engineer to support the Formulation, Laboratory & Experimentation center (FLEx) for non-sterile operations.

The role covers equipment and facility maintenance, validation support from commissioning through decommissioning, and collaboration with GES, Facilities Management, OEMs and vendors to ensure GMP and safety compliance during second shift, Monday through Friday.

Qualifications

• Bachelor’s degree in engineering with 2+ years in pharmaceutical manufacturing.
• Strong familiarity with Quality, cGMP, Safety & Environmental Policies.
• Familiarity with CMMS.
• Ability to adapt across Quality and Facility areas to support the business.
• Effective organizational skills and communication; strong technical writing.
• Strong computer skills.

Responsibilities

• Maintain facility, utilities, and manufacturing equipment in GMP and safety compliance.
• Support equipment validation from commissioning through decommissioning.
• Manage changes, periodic reviews, deviations, and CAPAs.
• Issue Quality Notifications; maintain GMP documentation.
• Support clinical operations; manage purchase orders and capital requests.
• Coordinate installation and commissioning of new equipment.
• Provide SME regulatory support as needed; liaison with GMP vendors.

Skills

Quality & cGMP

Adaptability

Organizational skills

Communication

Technical writing

Computer skills

Education

Bachelor’s degree in engineering

Tools

CMMS

SAP PM

eVal/Kneat

ProCal CCMS

Job description

Job Description

This Engineer position provides on-site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift), Monday through Friday, is required to meet operational needs. The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products, including process development, scale-up, launch and transfer to the supply network, and process optimization for commercial products. The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements while applying Reliability Maintenance best practices to support timely availability of clinical and development batches. This includes troubleshooting equipment, partnering with GES, Facilities Management, OEMs, and vendors, and providing engineering and compliance support for non-sterile process equipment and utilities. The role operates with minimal supervision and serves as a technical and compliance resource during second shift operations. Responsibilities include supporting equipment validation from commissioning through decommissioning, managing changes and periodic reviews, investigating deviations, issuing Quality Notifications, identifying root causes and CAPAs, maintaining GMP documentation, supporting clinical operations, managing purchase orders and capital requests, coordinating installation and commissioning of new equipment, and supporting regulatory interactions as an SME when needed.

Education

Bachelor’s degree in engineering plus a minimum of 2 years of related experience supporting pharmaceutical manufacturing.

Required Experience And Skills

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.
• Effective organizational skills.
• Effective communication and technical writing skills.
• Strong computer skills

Preferred Experience And Skills

• Familiarity with Oral Solid Dosage (OSD) Drug Product manufacturing equipment and process.
• Troubleshooting ability (mechanical/electrical/automation)
• Maintenance & Engineering techniques and management and Capital Project management.
• Independent problem- solving.
• SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
• eVal/Kneat - Paperless electronic validation system
• Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with Planning and Scheduling practices as well as business/financial practices.
• The candidate should be able to work independently and lead or facilitate tasks successfully.

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.

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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Primary Location

USA - New Jersey - Rahway

Salary Range

$87,300.00 - $137,400.00

Benefits

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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Requisition ID

R424343

Required Skills

cGMP Guidelines, Engineering Support, Laboratory Experiments, Maintenance Management Systems, Maintenance Supervision, Manufacturing, Pharmaceutical Manufacturing, Pharmaceutical Sciences, Pilot Plant Operations, Process Engineering, Process Equipment, SAP PM Module, Solid Dosage Forms, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing