Technical Operations Engineer (On-site)

MSD • Rahway, NJ

1d • Onsite

About The Position

The Specialist, Engineering serves as a Technical Operations Engineer supporting FLEx Non-Sterile clinical manufacturing operations. The position owns manufacturing equipment or technical capability areas and supports equipment readiness, production campaigns, troubleshooting, investigations, engineering changes, and continuous improvement. It combines hands-on manufacturing-floor support with technical problem solving, documentation, data analysis, and sustained improvement of equipment and operational systems.

The engineer works closely with Production, Process Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, and other stakeholders. The role also provides equipment and operations expertise for capital projects, upgrades, commissioning, qualification, startup, and capability expansion. The position is based at the primary location in Rahway, New Jersey, and is on-site in a manufacturing environment.

Requirements

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

Nice To Haves

• 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.
• Pharmaceutical manufacturing experience.

Responsibilities

• Own one or more manufacturing equipment trains or technical capability areas within FLEx Non-Sterile operations.
• Maintain equipment readiness through preventive action tracking, performance and alarm review, procedural updates, training support, and coordination of 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 subject matter experts to resolve equipment and system issues.
• Support equipment changes, automation or mechanical improvements, and change control activities.
• Develop and maintain equipment knowledge, technical references, standard work, and lessons learned; coach and train colleagues.
• Coordinate equipment, room, utility, documentation, training, material, and technical needs for campaign readiness.
• Provide on-floor engineering support during manufacturing campaigns, turnovers, changeovers, and other critical operations.
• Respond to escalations, clarify ownership, stabilize immediate concerns, and coordinate resolution.
• Partner with Production and Process Engineering to identify schedule constraints, assess technical risks, and support recovery plans.
• Support batch execution and closeout, and participate in shift handoffs and cross-shift support.
• Lead or support troubleshooting, deviation and atypical-event investigations, root cause analysis, and corrective and preventive actions for equipment, automation, and operational issues.
• Use 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 complies with GMP, Good Documentation Practices, safety, environmental, and company requirements; support audit readiness, inspections, walkthroughs, and action closure.
• Promote early escalation and collaborative resolution of risks and problems.
• Lead focused improvement initiatives 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.
• Improve standard work, production flow, issue tracking, knowledge management, and visual management practices.
• Partner with operations and technical stakeholders to test, implement, and sustain tools, equipment upgrades, and automation solutions; track actions and communicate status, risks, decisions, and results.
• Provide equipment and operations expertise for capital projects, equipment upgrades, and capability expansion initiatives.
• Participate, as assigned, in design reviews, risk assessments, vendor engagement, FAT/SAT activities, commissioning, qualification, startup, and operational handover.
• Represent operational requirements for 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.
• Communicate technical information to operators, engineers, scientists, mechanics, automation personnel, quality representatives, and leadership.
• Contribute to team standard work, technical reviews, knowledge sharing, and continuous improvement priorities.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level