Based at our GMP Manufacturing facility in Norwood, MA this position will lead a cohesive team responsible for maintenance, calibration and repairs of GMP process and support equipment In our South Facility. The Director will apply existing and new knowledge of manufacturing equipment maintenance, calibration and cGMPs to enable technical success with stringent adherence to regulatory requirements and Moderna's Quality System.
Here's What You'll Do
Here's What You'll Bring To The Table
- Develop weekly/monthly/annual goals.
- Responsible for establishing installation readiness and maintenance of equipment in support of manufacturing and laboratories.
- Implement standards and framework for continuous improvement in quality, safety, operational readiness, and energy efficiency for systems, infrastructure, and operations, including metrics and reporting methods.
- Oversee progress of daily schedule to ensure safe and timely completion of activities.
- Ensure compliance with GMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records.
- Oversee the hiring, development, retention and performance of staff.
- Ensure performance of preventative and corrective maintenance, calibration activities. Lead efforts in developing remediation for follow-up and emergency work.
- Lead troubleshooting on equipment and systems, including development of remediation activities for issues with multiple systems and equipment 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.
- Develop and implement reliability program
- Provide subject matter expertise for the operation and maintenance utility and support systems.
- Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.
- Oversee the scheduling and planning function
- Oversee Engineering Spare Parts
- Coordinate all equipment moves from site to site
- Develop all engineering and technical staff as appropriate
- Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.
- Support and own Change Controls, CAPAs and Deviations
- Ensure that spare parts, tools and equipment are available to complete all assigned tasks
- Respond to alarms and document activities. Working with equipment owners, 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
- Support regulatory, partner and internal audits.
- Other duties as required.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- At least 20 years relevant experience working in a regulated (cGMP preferred) environment with 10 years of supervisory experience with a post-secondary degree in a science/technical field, a technical trade school degree or military training experience.
- Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.
- Experience with Metrology preferred.
- Understanding of PLC controls for simple troubleshooting is required.
- Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able 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 his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to find true root cause and path forward for complex problems.
- Demonstrated ability to learn new equipment/systems.
- Familiarity with Excel, Word, and PowerPoint are required.
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
- Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.
- Demonstrated project management skills
- 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
- Mental Toughness
- 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 winter shut down
• 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.
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