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Job Responsibilities & Duties:

· 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, 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 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.

· Other responsibilities to support team projects and proactive initiatives

· Author, revise, and maintain Equipment/Instrument SOP’s

· Coordinate and schedule calibration/maintenance activities with Facilities, Metrology and QC to ensure timely completion and minimize equipment down and address OOT (Out of Tolerance) events.

· Review of preventative maintenance reports, calibration certifications, CMMS records, perform system inventory audits.

· Submit asset induction, work and administrative requests to ensure equipment failure is addressed immediately and information is CMMS is accurate and in proper state.

· Attending cross-functional meetings.

Qualifications:

· 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

· Technical writing skills.

· 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.

· Demonstrated ability to work effectively under established guidelines and instructions.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.