Moderna is seeking a QC Equipment Specialist with strong laboratory equipment IOPQ, calibration, maintenance and troubleshooting skills. Individual in this roll is highly independent and self-motivated. He/She must have demonstrated solid scientific and technical breadth to support laboratory equipment life cycle management in a biopharmaceutical manufacturing facility. The person in this role will also handle deviation investigation, change control, corrective actions and preventive actions (CAPAs). This role is assigned to Monday to Friday, day shift.
Here's What You'll Do
Here's What You'll Need (Minimum Qualifications)
- Supports 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, coordinate and communicate equipment lifecycle (acquisition, qualification / validation, Implementation, decommission) management timelines using project management tools.
- Ensure the equipment documentation meet cGMP, GDP and data integrity requirements.
- Ordering supplies and maintaining inventory for equipment consumables/accessories.
- 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. Ensure the vendor representatives follow Moderna's procedures including safety requirements when they are onsite.
- 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 downtime 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.
- Follow the safety and cGMP requirements in laboratories during equipment IOPQ, calibration, maintenance, and troubleshooting.
- Additional duties as may be assigned from time to time
Here's What You'll Bring to the Table (Preferred Qualifications)
- Minimum education required: Bachelor's degree in science or engineering discipline
- Minimum experience required: 5 years of industry experience in a cGMP laboratory setting
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Familiar with equipment software, troubleshooting and maintenance in analytical chemistry, biochemistry, microbiology laboratories
- Strong skills with GMP/GDP/QC Data review and attention to details
- Demonstrate the understanding cGMP compliance and criticality of instrument IOPQ/calibration
- Familiar with computerized management maintenance system (CMMS)
- Experience with cGMP deviation investigation, change control, CAPA implementation, and effectiveness check
- Solid technical writing and data interpretation skills
- Strong organization and 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
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
- Details and results oriented
- Outstanding ability to multi-task
- Strong sense of urgency
- Ownership to the projects and commitment to meet the timelines
- Solid knowledge of lab safety
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.