Manager, Validation

The Role:

Reporting to the Associate Director F&E, the Validation Manager will be responsible for the delivery of the qualification programs, ensuring equipment and systems are qualified and in an operational state of compliance associated with cGMP manufacturing environments. This individual will work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.

Heres What Youll Do:

• Provide guidance / supervision to Moderna Validation Engineers as well as external validation service providers.

• Assists in development of validation standards and templates

• Provide validation subject matter expertise / support for equipment and systems in use at Moderna facilities including but not limited to Aseptic Fillers, Isolators, Formulation Systems, Controlled Temperature Units, Analytical Instruments, Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters.

• Track and report status on metrics relevant to the operations qualification programs activities / responsibilities and ensure commitment to key stakeholders are met.

• Ensure the validated status of site facilities, utilities, equipment is established in accordance with internal procedures, regulatory requirements and industry guidance / standards.

• Define and execute the validation strategy associated with operations, covering a range of facilities, utilities, equipment and processes in accordance with manufacturing timelines.

• Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.

Heres What Youll Bring to the Table:

• B.S. in Chemical or Mechanical Engineering. B.S. degrees in other scientific or health-related fields will be considered.

• Minimum of 8 years in commissioning / qualification / validation experience in cGMP manufacturing environments

• Proven experience leading validation teams

• Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE); especially fil finish systems and equipment

• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.

• 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.

• 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 manager.

• Ability to represent Modernas interests, objectives and policies in a professional and responsible manner.

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 persons 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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