Specialist Engineering (Onsite)

Merck; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Merck in Rahway, NJ seeks an on-site engineer to support non-sterile operations in the FLEx center. The role covers equipment and facilities maintenance, GMP compliance, and manufacturing support for clinical, stability, and development batches on the second shift (Mon-Fri).

Responsibilities include equipment validation, change control, deviation investigations, CAPAs, GMP documentation, and collaboration with GES, Facilities, OEMs, and vendors. Strong CMMS and SAP PM skills are required.

Qualifications

• Bachelor's degree in engineering
• 2+ years of related pharma/manufacturing experience
• Strong familiarity with Quality, cGMP, Safety & Environmental Policies
• Familiarity with CMMS
• Able to adapt across Quality and Facility aspects
• Strong organizational skills
• Effective communication and technical writing skills
• Strong computer skills

Responsibilities

• Maintain facility, utilities and equipment in GMP compliance.
• Support equipment validation from commissioning through decommissioning.
• Manage changes and periodic reviews; investigate deviations and issue Quality Notifications.
• Identify root causes and CAPAs; maintain GMP documentation.
• Support clinical operations and regulatory interactions as SME when needed.
• Coordinate installation and commissioning of new equipment; manage POs and capital requests.

Skills

Quality & cGMP

CMMS

Communication

Documentation

Computer skills

SOP Writing

Process Engineering

SAP PM Module

Validation

Education

Bachelor's degree in engineering

Tools

CMMS

SAP PM Module

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.

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

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.

Equal Employment Opportunity

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.

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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Location

USA - New Jersey - Rahway

Where required b