Technical Operations Engineer (On-site)

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

Job summary

MSD in Rahway, NJ, is seeking a Specialist, Engineering to support FLEx Non-Sterile clinical manufacturing operations. You will own equipment trains, ensure production readiness, provide on-floor technical support, troubleshoot, investigate, and drive continuous improvement to deliver safe, compliant clinical supplies.

This role collaborates with Production, Process Engineering, Quality, Facilities, Maintenance, Automation and other teams; you will document work, use data, and support change

Qualifications

• B.S. or M.S. degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industrial experience.
• Experience supporting technical work in regulated environments; strong documentation and cross-functional collaboration.
• Knowledge of GMP and Good Documentation Practices; ability to work in a compliant and safety-focused environment.

Responsibilities

• Own one or more manufacturing equipment trains and maintain readiness; coordinate with multiple teams to resolve issues.
• Provide on-floor engineering support during campaigns, turnovers, changeovers, and critical operations.
• Lead or support troubleshooting, deviations, investigations, and CAPAs; ensure timely closure of actions.

Skills

Troubleshooting

Documentation

Cross-functional collaboration

Problem solving

Education

B.S. or M.S. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences

Tools

PAS-X

SAP

PI/historian

Power BI

Job description

Job Description Role Overview

The Specialist, Engineering serves as a Tech Ops Engineer supporting FLEx Non-Sterile clinical manufacturing operations. This role is responsible for equipment ownership, production readiness, on-floor technical support, troubleshooting, investigation support, engineering change execution, and continuous improvement to enable safe, reliable, and compliant delivery of clinical supplies. The engineer partners closely with Production, Process Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, and other program stakeholders. The position combines hands-on manufacturing support with technical problem solving, documentation, data use, and sustained improvement of equipment and operational systems.

Primary Responsibilities

Equipment Ownership & Technical Readiness: Own one or more manufacturing equipment trains or technical capability areas within FLEx Non-Sterile operations. Maintain equipment readiness through preventive action tracking, alarm and performance review, procedural updates, training support, and coordination of required maintenance or engineering work. Serve as a technical point of contact for equipment operation, setup, changeover, cleaning, assembly, disassembly, and troubleshooting. Coordinate with Process Engineering, Maintenance, Automation, Facilities, vendors, and other subject matter experts to resolve equipment and system issues. Support equipment changes, automation or mechanical improvements, and change control activities in accordance with applicable procedures. Develop and maintain equipment knowledge, technical references, standard work, and lessons learned; share knowledge through coaching and training.

Production Readiness & Operational Support: Support campaign readiness by coordinating equipment, room, utility, documentation, training, material, and technical support needs. Provide on-floor engineering support during manufacturing campaigns, turnovers, changeovers, and other critical operations. Respond to escalations, clarify ownership, stabilize immediate concerns, and coordinate an effective path to resolution. Partner with Production and Process Engineering to identify schedule constraints, assess technical risks, and support recovery plans. Support batch execution and closeout activities as needed to ensure safe, compliant, and reliable production. Participate in shift handoffs and cross-shift support to maintain continuity of technical information and actions.

Investigations, Problem Solving & Compliance: Lead or support troubleshooting, deviation and atypical-event investigations, root cause analysis, and corrective and preventive actions for equipment, automation, and operational issues. Apply structured problem-solving methods to identify root causes, establish sustainable actions, and verify effectiveness. Author, revise, and review GMP documentation, including SOPs, batch or equipment instructions, risk assessments, change controls, investigation records, and technical assessments. Ensure work is performed in compliance with GMP, Good Documentation Practices, safety, environmental, and company requirements. Support audit readiness, internal and external inspections, walkthroughs, and timely closure of identified actions. Promote a learning-focused escalation culture that encourages early identification of risk and collaborative resolution of problems.

Continuous Improvement & Digital Manufacturing: Lead focused improvement initiatives for assigned equipment or processes to improve safety, quality, reliability, capacity, turnaround time, and ease of execution. Use operational data, batch reports, alarm history, downtime information, and action trackers to identify recurring issues and improvement opportunities. Support digital manufacturing systems and workflows, including electronic batch records and logs, dashboards, scheduling tools, historian data, and escalation tracking. Define and improve standard work, production flow, issue tracking, knowledge management, and visual management practices. Partner with operations and technical stakeholders to test, implement, and sustain new tools, equipment upgrades, and automation solutions. Track actions to completion and communicate status, risks, decisions, and results to affected stakeholders.

Capital Projects & Capability Expansion: Provide operations and equipment subject matter expertise for capital projects, equipment upgrades, and capability expansion initiatives. Participate in design reviews, risk assessments, vendor engagement, FAT/SAT activities, commissioning, qualification, startup, and operational handover, as assigned. Represent operational requirements for equipment usability, cleaning, maintenance, training, documentation, digital integration, and long-term support. Coordinate project work with the manufacturing schedule and support safe, controlled return of equipment or areas to service. Identify opportunities to expand equipment operating ranges, change-part capability, manufacturing flexibility, and asset utilization.

Collaboration & Team Development: Communicate technical information clearly to operators, engineers, scientists, mechanics, automation personnel, quality representatives, and leadership. Coach and train colleagues on assigned equipment, standard work, troubleshooting approaches, and compliant execution. Contribute to team standard work, technical reviews, knowledge sharing, and continuous improvement priorities.

Education Minimum Requirements

B.S. or M.S. degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industrial experience.

Required Qualifications

Experience supporting technical work, manufacturing operations, equipment, or process improvement in a laboratory, pilot plant, pharmaceutical, biotechnology, or other regulated environment. Demonstrated ability to troubleshoot technical problems, organize actions, and drive issues toward resolution. Ability to author and review clear technical documentation and work in accordance with controlled procedures. Strong planning, prioritization, communication, and cross-functional collaboration skills. Ability to work effectively in an on-site manufacturing environment and support changing operational priorities. Ability to meet applicable medical screening and physical requirements for the manufacturing area.

Preferred Qualifications

Experience in GMP pharmaceutical or biotechnology manufacturing and knowledge of Good Documentation Practices. Experience with oral solid dosage or specialty processes such as tablet compression, encapsulation, spray drying, film coating, blending, granulation, powder handling, containment, or device assembly. Experience with equipment ownership, maintenance coordination, automation troubleshooting, investigations, CAPAs, change controls, or risk assessments. Experience supporting capital projects, commissioning, qualification, validation, FAT/SAT, or equipment startup. Experience with Lean, Six Sigma, structured problem solving, or continuous improvement methods. Experience with digital manufacturing systems and tools such as PAS-X, SAP, PI/historian systems, Power BI, data analytics platforms, or maintenance/calibration systems. Experience using data to evaluate equipment performance, downtime, capacity, or recurring operational issues.

EligibleforERP Required Skills

Batch Production Records, cGMP Guidelines, Chemical Engineering, Engineering Support, Equipment Maintenance, Manufacturing, Manufacturing Systems, Pilot Plant Operations, Process Engineering, Process Optimization, Production Support, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

Preferred Skills

Pharmaceutical 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. 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.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10% Flexible Work Arrangements: Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

11/11/2026

Compensation and Benefits

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $87,300.00 - $137,400.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

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. Additional location(s) Compensation Information:

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.

About the Company

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.