Engineer, Validation

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
May 17 2019
Ref
R1648
Discipline
Life Sciences, Biology
Organization Type
Biotech
Engineer, Validation

The Role:

Reporting to the Associate Director of Quality Systems and Compliance, this person will be responsible for manufacturing, quality control and validation projects in Norwood, MA. This entails ensuring cGMP compliance of process, facility, utilities, equipment, method and computer system validation and execution of validation activities across the Moderna drug development ecosystem. The role is responsible for performing risk and impact/criticality assessments, writing validation plans, protocols and reports, executing validation activities, and review and approval of all validation records and documentation. The scope of responsibility includes commissioning, qualification and validation (CQV) of equipment, computer system validation, cleaning validation, process validation, and method validation/transfers and ensuring compliance with in-house specifications/standards/ procedures, regulations and guidance documents, and Good Manufacturing Practices.

This role will partner with system owners, subject matter experts, and digital to drive testing and implementation of all manufacturing applications and infrastructure to the desired quality standards.

Here's What You'll Do:
  • Execute and provide oversight of validation activities to maintain compliance at Moderna's current cGMP manufacturing facility in Norwood, MA which includes Raw Material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities.
  • Responsible for supporting the qualification and requalification of cGMP utilities, manufacturing process equipment and QC laboratory equipment; meeting timelines and project due dates; Cleaning Validation program.
  • Responsible for authoring, executing and review/approval of design and commissioning documentation, validation protocols, 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 deviations related to manufacturing process equipment, utilities, automation, computer systems, methods and QC laboratory instruments.
  • Responsible for performing change control assessments and reviewing/approving change control implementation plans for facilities, utilities, systems, equipment, process, method, laboratory instruments and computer system validation.
  • Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method, laboratory instruments, and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
  • Responsible for supporting internal and external inspections as a subject matter expert for Validation; delivers high quality, risk based, compliant validation packages.
  • Ensure SOPs and procedures are created, understood and followed. Leads continuous quality system improvements for the validation program.


Here's What You'll Bring to the Table:
  • Bachelor's degree in a scientific or health-related field required.
  • Minimum of 5 years of Validation experience in the biotechnology or pharmaceutical industries required.
  • Experience in GXP IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environments is a plus.
  • Experience with multi-product facilities and developing and managing cleaning validation programs.
  • 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.
  • Ability to interact effectively with all levels of personnel within the organization.
  • Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
  • Proven ability to manage projects while meeting all deliverables and timelines.
  • Strong knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
  • Demonstrate strong organizational skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
  • Practical experience with Quality by Design is a plus.


Here's What We'll Bring to the Table:
  • On-site subsidized cafeteria
  • 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
  • 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.


Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-PL1

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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