Engineer II, QAV
ModernaTX, Inc.

Job Info

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The Role:

Reporting to the Manager, Quality Assurance, Validation, this person will be responsible for cGMP compliance of process, facility, utilities, equipment, method and computer system validation and will be accountable for their execution across the Moderna drug development ecosystem. The role is responsible for ensuring review and approval of all validation records and documentation (i.e. equipment qualification, cleaning validation, and computer system validation) are compliant with in-house specifications/standards/procedures and Good Manufacturing Practices.

Here's What You'll Do:

• Provide QA oversight of commissioning, qualification and validation activities.
  
• Responsible for supporting the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
  
• Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
  
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
  
• Participate in cross functional meetings for planning and discussing of changes to be commissioned, qualified, validated equipment/facilities/utilities.
  
• Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
  
• Use critical thinking skills to partner with CQV and facility engineers to problem solve.
  

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

• Minimum education requirement is a Bachelor's degree, preferably in Sciences or Engineering with 2-5 years of experience. Preferably in Validation.
  
• Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environment is a plus.
  
• Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Uses a team-oriented approach to project management and problem resolution.
  
• Excellent understanding of QA principles, validation principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Ability to interact effectively with all levels of personnel within the organization.
  
• Ability to translate complex issues into a meaningful set of recommendations
  
• Demonstrated knowledge of cGMPs in a manufacturing environment
  
• Strong independent judgement and decision-making abilities
  
• Demonstrated problem detection and problem resolution skills
  
• Must possess demonstrated organizational skills
  
• Must possess excellent verbal and written
  

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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