Associate Director / Director Validation, Facilities and Engineering
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POST DATE 7/31/2020
END DATE 9/26/2020
JOB DESCRIPTIONTHE ROLE:
Reporting to the Sr. Director Facilities and Engineering, this position will be the owner of the Commissioning, Qualification and Validation (CQV) program and will be the SME for all qualification activities. The role is responsible for cGMP compliance of facility, utilities, equipment, method and computer system validation and their execution across the Moderna drug development ecosystem. Also, ensuring execution, review and approval of all validation records and documentation (i.e, computer system validation, method validation/transfer, and equipment lifecycle documentation) and ensuring they are compliant with Moderna specifications/standards/procedures and current Good Manufacturing Practices.
HERE S WHAT YOU LL DO:
* Provide oversight of commissioning, qualification and validation activities for Moderna s early phase GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities.
* Establish and maintain policies and procedures for the CQV function, ensuring Quality By Design and Safety By Design concepts are well integrated in the CQV approach.
* Manage/perform the execution, 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.
* Leads and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
* Perform change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
* Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
* Support internal and external inspections as a Subject Matter Expert for Commissioning, Qualification and Validation.
* Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
* Oversight of contractors/consultants in the day to day execution of CQV scope and projects, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product.
* Develops, monitors and reports departmental metrics
* Creates and maintains CQV SOPs, Validation Master Plans and protocols
* Requalification program development and execution including set up of requalification work orders in the CMMS
* Ensuring ETOP packages are created and maintained
HERE S WHAT YOU LL BRING TO THE TABLE:
* Minimum education requirement is a Bachelor s degree, preferably in Sciences or Engineering with 10+ years of experience. Preferably in Validation/Engineering.
* Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environment and with late phase / commercial launch experience is a plus.
* Familiarity with biotechnology operations, including GMPs. Knowledge of clean room design, GMP HVAC, grey utilities, and GMP utilities.
* 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, serve on multiple interdepartmental teams and act as team leader when appropriate.
* Proven ability to manage projects while meeting all deliverables and timelines.
* Strong knowledge of validation standards and current industry best practices and global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, FDA and EU GMPs, 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.
* Experience in third party and regulatory audits.
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)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
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, 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.