Sr. Engineering Services Specialist
ModernaTX, Inc.

Job Info

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The Role:

Moderna is seeking a cGMP Senior Facilities Specialist based in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for maintaining GMP systems and equipment. The Specialist uses expert knowledge of cGMP regulations, biopharmaceutical systems and equipment to manage investigations and improvement initiatives within the Facilities & Engineering organization.

Here's What You'll Do:

• Serves as the Facilities and Engineering site representative for quality system (Deviations, CAPAs, Change Controls) execution and metric tracking.
  
• Practices and promotes safe work habits and adheres to safety procedures and guidelines
  
• 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
  
• 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
  

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

• Bachelor's Degree with minimum of 10 years of experience in biopharmaceutical operations
  
• Subject matter expertise in biologics equipment (Chromatography, TFF, Mixing Vessels, Fermenters), maintenance and calibration
  
• 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 Engineering or Life 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 requirements
  
• Background in lean methodologies and operational excellence
  
• 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)

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 10 years since its inception,Modernahas transformed from a science 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 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.Modernamaintains 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.Modernahas been named a top biopharmaceutical employer bySciencefor 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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