Sr. Validation Engineer
Reporting to the Sr. Director Quality Assurance, this person will be responsible for manufacturing, quality control and quality assurance validation projects within Moderna manufacturing facilities. This position will eventually transition to our new GMP Manufacturing site 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 IT to drive testing and implementation of all manufacturing applications and infrastructure to the desired quality standards.
- Execute and provide oversight of validation activities to maintain compliance of Moderna's current GMP manufacturing facilities in Cambridge, MA and Moderna's new early phase GMP manufacturing facility in Norwood, MA which includes Raw Material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities.
- 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 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.
- Ensure SOPs and procedures are created, understood and followed. Leads continuous quality system improvements for the validation program.
- Delivers high quality, risk based, compliant validation packages
- 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 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.
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.