Engineering Services Manager at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:

Moderna is seeking a Manager of Engineering Services based in Norwood, MA.

Reporting to the AD of Engineering, the Manager of Engineering Services will be responsible for supporting the Facilities, Engineering, and Validation teams with compliance related cGMP activities such as Deviations, CAPAs, Change Controls, and Risk Assessments. The role will also be responsible for Engineering documentation management, including, but not limited to, Engineering Turnover Packages, Site Drawings, P&IDs, and CAD drawings. Additional responsibility includes execution of improvement initiatives within the Facilities, Engineering, and Validation organization.

This role will also be responsible for the management of the Engineering Services team, which includes, Engineering Services Engineers, Engineering Documentation Managers, and CAD drafters.

Here's What You'll Do:

• Supervise and lead Engineering Services Engineers, Engineering Documentation Managers, and CAD drafters. Provide technical guidance, coaching, and work prioritization assistance with the team.




• Utilizes Facilities & Engineering knowledge and investigational skills to identify and resolve issues to drive continuous improvement




• Conducts complex document revisions and/or document management including SOPs, work plans, calibration specifications




• Maintains the GMP state of regulatory drawings / documents




• Works independently with minimal supervision and direction




• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion




• Creates and presents trending and metrics reports for quality events




• Provide project management of initiatives across the Facilities & Engineering organization Practices and promotes safe work habits and adheres to safety procedures and guideline

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

• Bachelor's Degree or equivalent experience with minimum of 10 years of experience in biopharmaceutical operations




• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment




• Minimum of 5 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment




• Excellent written and oral English language skills




• Bachelor's degree in Sciences is preferred




• Demonstrated ability to lead cross functional teams and deliver results with minimal supervision




• Ability to manage multiple competing priorities in a fast-paced environment




• Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements




• Experience interacting with representatives of regulatory agencies




• Project management experience

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches


• Company-provided iPhone


• Free parking, monthly subway pass or a subsidized commuter rail pass


• Free annual corporate membership to Bluebikes


• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP


• Flexible Spending Accounts for medical expenses and dependent care expenses


• 16 weeks of 100% paid parental leave for all new parents


• 16 weeks 100% paid family caregiver leave


• 20 weeks 100% paid medical leave


• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)


• Adoption assistance and discounts to local childcare centers, as well as access to care.com


• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately


• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability


• Voluntary legal assistance plan


• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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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