The Production Engineer will provide hands‐on technical support to ensure operability, reliability, and compliance of our mRNA drug‐product manufacturing and fill‐finish equipment. This includes single‐use mixers, parts washer, autoclave, isolator, filling machine, and supporting utilities. The Engineer will work closely with Manufacturing, Facilities & Engineering, MS&T, Quality, Production, OEM vendors, calibration teams, and Process Technicians (mechanical and electrical) to troubleshoot, optimize, and sustain critical equipment throughout its lifecycle in a fast‐paced 24x7 GMP environment.
Here's What You'll Do
Daily Operations & Support
* Ensure in‐scope equipment (single‐use mixers, parts washer, autoclave, isolator, filling machine, utilities) meets compliance, safety, and business requirements.
* Respond to alarms, OOS, OOT events; perform product impact assessments and initiate containment actions.
Tier1 Operations Meetings
* Represent Engineering to review and prioritize equipment issues impacting product quality and overall equipment effectiveness (OEE).
* Track action items, communicate status, and escalate unresolved critical issues.
Troubleshooting & Reliability
* Lead root‐cause analyses (5‐Why, Fishbone) for equipment failures; develop corrective and preventive action plans and supporting change controls.
* Collaborate with mechanical and electrical technicians to diagnose and resolve failures in drives, valves, sensors, control loops, and utility networks.
Commissioning, Validation & Compliance
* Assist with commissioning, qualification, and validation protocols (URS, IQ/OQ/PQ) for new and modified equipment.
* Maintain and update cGMP documentation (SOPs, SWPMs, batch records) and support internal/external audits.
Original Equipment Manufacturer OEM & Calibration Partnerships
* Liaise with OEM vendors for installations, commissioning, warranty repairs, and technical escalations.
* Coordinate with in‐house and third‐party calibration teams to schedule and verify calibration of critical instrumentation.
Project Participation & Continuous Improvement
* Support engineering projects across all phases: user requirements, design reviews, procurement, installation, start‐up, commissioning, and handover.
* Analyze equipment performance and CMMS data; propose improvements to preventive maintenance strategies and reliability programs.
Here's What You'll Need (Basic Qualifications)
* Bachelor's degree in Chemical, Mechanical, Mechatronics or related engineering discipline.
* 2–4 years of relevant experience in pharmaceutical or bioprocess manufacturing (GxP/GMP environment preferred).
* Exposure to drug‐product equipment is preferred (mixers, isolators, filling lines, autoclaves, parts washers, automated inspection and packing machines).
* Basic hands‐on troubleshooting of PLC/HMI/SCADA systems, variable‐speed drives, and pneumatic/vacuum loops.
* Experience assisting with CQV activities and drafting validation deliverables.
* Familiarity with CMMS, Excel (pivot tables, charts), Word, and PowerPoint.
* Excellent interpersonal and communication skills; ability to present technical findings and influence cross‐functional teams.
* Self‐starter with strong problem‐solving skills, adaptability for 24x7 operations, and eagerness to learn under mentorship.
* Professional demeanour; able to represent Moderna's interests and policies.
* This position is site‐based, requiring you to be at Moderna's site full‐time. This position is not eligible for remote work.
* As part of Moderna's commitment to workplace health and safety, this role may be subject to pre‐employment and periodic medical assessments, in line with relevant legal and operational requirements.
Pay & Benefits
* Best‐in‐class healthcare, plus voluntary benefit programs to support your unique needs.
* A holistic approach to well‐being with access to fitness, mindfulness, and mental health support.
* Family building benefits, including fertility, adoption, and surrogacy support.
* Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‐end shutdown.
* Savings and investments to help you plan for the future.
* Location‐specific perks and extras.
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
Moderna is committed to equal opportunity in employment and non‐discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .
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