Technician IV, PCV

The Role: Based at our new cGMP Manufacturing facility in Burlington, MA, this position will be responsible for calibration, maintenance, and repairs of GMP/non-GMP process systems and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers Here’s What You’ll Do: Perform preventative and corrective maintenance activities and calibrations to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work. Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors. Maintain cGMP records, both paper-based and electronic. Understand Asset Management and routine reliability concepts. Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks. Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, and UV among others in a GMP/GXP environment. Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities. Provide “on-call” support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed. Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks. Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP’s, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements. Administer and perform hazardous energy control procedures and confined space entry. Other duties as required. Here’s What You’ll Bring to the Table: Minimum AS degree in a science/technical field or a technical trade school with 10 years of relevant experience working in a regulated (cGMP preferred) environment. Preferred BS Degree with 8 years of relevant experience Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work. Military training equivalent of above is acceptable. Experience with Metrology. Understanding of PLC controls for simple troubleshooting is preferred. Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. Must have a customer service mindset. Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach to determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems. Familiarity with Excel, Word, and PowerPoint. Ability to navigate computerized data and information management systems. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner. Ability to work in fast-paced manufacturing environment. Respect for People. Ability to work collaboratively. Creative Problem Solving. Decision Making. Exemplary Work Ethic, Driven by the Mission. Impeccable Integrity. Risk Taking / Accountability. Humility. Mental Toughness. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: 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. #LI-NM1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home