QC Equipment Specialist

2 months ago

Norwood, United States Tek Labs Inc Full time

Job Opportunity: QC Equipment Specialist (Validation Engineer)
Location: Norwood, MA, USA
Duration: 6+ Months (with potential for extension and conversion to full-time)

Are you an experienced professional with a strong background in QC equipment validation and maintenance? Moderna is looking for a QC Equipment Specialist (Validation Engineer) to join our dynamic team. If you thrive in a cGMP laboratory setting and have a passion for equipment troubleshooting and lifecycle management, we encourage you to apply

Job Description:

Support team to investigate and resolve issues related to equipment failures, system deficiencies, deviations, and equipment troubleshooting.
Support authoring quality systems records such as deviations, change controls, and CAPAs as required.
Monitor and communicate method lifecycle (acquisition, qualification/validation, implementation) timelines using project management tools.
Ordering supplies and maintaining inventory for equipment consumables/accessories.
CTU alarm response, calibration, and re-qualification coordinating and scheduling.
Assist with locating and collecting assets due for service and returning to the laboratory when complete.
Train QC analysts on equipment operation.
Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors onsite and externally.
Perform as-needed non-invasive repairs on UHPLC systems such as changing capillaries, flow cells, needles/seats as well as perform basic troubleshooting.
Author, revise, and maintain Equipment/Instrument SOPs.
Coordinate and schedule calibration/maintenance activities with Facilities, Metrology, and QC to ensure timely completion, minimize equipment downtime, and address OOT (Out of Tolerance) events.
Review preventative maintenance reports, calibration certifications, and CMMS records, and perform system inventory audits.
Submit asset induction, work, and administrative requests to ensure equipment failure is addressed immediately and information in CMMS is accurate and in proper state.
Attend cross-functional meetings.

Here’s What You’ll Bring to the Table:

Bachelor’s degree in sciences and at least 5 years of industry experience in a cGMP laboratory setting.
Familiar with analytical equipment troubleshooting and maintenance.
Strong skills with GMP/GDP/QC Data review and attention to detail.
Familiar with CMMS systems and technical writing.
Strong communication skills (verbal and written); ability to collaborate effectively in a dynamic, cross-functional matrix environment (QC, QA, Validation, Digital, Vendors) to ensure equipment is serviced on time.
Experience with CTU (Controlled Temperature Units) and equipment calibration.
Proficiency with Microsoft Office Programs.
Demonstrated ability to work effectively under established guidelines and instructions.

Join our client team and contribute to impactful projects in a fast-paced environment. Apply now to take the next step in your career

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