Associate Specialist, Technical Operations Engineer (On-site)

1000 Merck Sharp & Dohme LLC; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

MSD in Rahway, NJ is seeking an Assoc. Specialist, Engineering to support FLEx Non-Sterile clinical manufacturing operations. You will own equipment trains, ensure readiness, provide on-floor technical support, and coordinate maintenance and changes.

The role blends hands-on manufacturing support with problem solving, documentation, and continuous improvement, partnering with Production, Process Engineering, Quality, Facilities, and Automation to enable safe, compliant production.

Qualifications

• Bachelor's or master's degree in a chemical/biomedical/pharmaceutical field or related discipline.
• Ability to troubleshoot technical problems and drive issues to resolution.
• Experience drafting and reviewing GMP documentation and controlled procedures.

Responsibilities

• Own equipment trains and ensure technical readiness of FLEx Non-Sterile operations.
• Provide on-floor engineering support during campaigns, changeovers, and turnovers.
• Lead or support investigations, root cause analysis, and CAPAs for equipment issues.
• Support digital manufacturing systems, dashboards, and data-driven improvements.
• Collaborate with cross-functional teams on capital projects and equipment upgrades.

Skills

Troubleshooting

Equipment ownership

Documentation

Education

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

Tools

PAS-X

SAP

Power BI

PI Historian

Job description

Role Overview

The Assoc. 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 expected graduation no later than December 2026).

Required Qualifications

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 supporting technical work, manufacturing operations, equipment, or process improvement in a laboratory, pilot plant, pharmaceutical, biotechnology, or other regulated environment.
• 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

Biomedical Engineering, Biopharmaceutical Operations, Chemical Engineering, Engineering Standards, Engineering Support, Manufacturing, Manufacturing Process Validation, Manufacturing Scale-Up, Manufacturing Systems, Pharmaceutical Sciences, Process Engineering, Production Support, Technical Calculations, Troubleshooting

Preferred Skills

Good Manufacturing Practices (GMP)

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 and Diversity Statement

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

Salary & Benefits

The salary range for the primary location of this role is: $71,900.00 - $113,200.00. 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 Locations / Compensation Information

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has additional 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 & Working Conditions

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

Job Posting End Date: 11/11/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.