Validation Manager
4 weeks ago
**The Role**:
Reporting to the Director, Engineering & Facilities, the Validation Manager will own the site Commissioning, Qualification and Validation (CQV) program and will be the SME for site qualification activities. This role will own the delivery of the site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance.
**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 and Finished Goods.
Provide guidance / supervision to staff and external validation service providers. Track and report status on metrics relevant to the re-qualification program activities / responsibilities and ensure commitment to key stakeholders are met.
Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
Leads and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
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, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product. Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment, and processes in accordance with project timelines and customer expectations.
Drive results by owning and completing validation initiatives / projects against identified timelines.
Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
Present validation documentation during regulatory / internal / customer audits. Participate in the response to regulatory audit observations, as required.
Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.
**Here’s What You’ll Bring to the Table**:
B.S. in Chemical or Mechanical Engineering.
Minimum of 7+ years in commissioning / qualification / validation experience in a Sterile cGMP manufacturing environment.
Proven experience leading teams; prior supervisory experience preferred.
Strong understanding of validation principles including but not limited to facilities, utilities, systems and equipment (FUSE).
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.
Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.
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 mínimal required direction from his / her manager.
Ability to represent Moderna’s interests, objectives and policies in a professional and responsible manner.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits of
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