Technical Operations Engineer (On-site)

Merck; Rahway (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Merck in Rahway, NJ is seeking a Specialist, Engineering to support FLEx Non-Sterile clinical manufacturing operations. You will own equipment trains, ensure production readiness, and provide on‑floor technical support.

The role involves troubleshooting, investigations, change control execution, and continuous improvement to enable safe, reliable delivery of clinical supplies. The engineer will collaborate with Production, Process Engineering, Quality, Facilities, and Automation teams to resolve

Qualifications

• Experience supporting clinical manufacturing operations in a regulated environment.
• Ability to own equipment trains and drive readiness activities.
• Strong problem-solving and root-cause analysis skills.

Responsibilities

• Own one or more manufacturing equipment trains or technical capability areas within FLEx Non‑Sterile operations.
• Maintain equipment readiness through preventive action tracking, alarms, performance reviews, and maintenance coordination.
• Provide on‑floor engineering support during campaigns, turnovers, and changeovers; troubleshoot and resolve issues.
• Lead or support investigations, deviations, and CAPA to ensure GMP compliance.
• Prepare and revise GMP documentation, SOPs, and change controls as needed.

Skills

Equipment ownership

Technical troubleshooting

Production readiness

Continuous improvement

Change control

Documentation

GMP compliance

On-floor support

Problem solving

Training/coaching

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.

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