Computer System Validation Manager Jobs in Mount Vernon, NY

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Job Description

Location: Ridgefield, New Jersey – Sterile Fill-Finish & Packaging Site

Our state-of-the-art sterile fill-finish and packaging facility in Ridgefield, NJ, is dedicated to meeting the growing needs of biotech and pharmaceutical drug developers. With expanded capabilities in pre-filled syringe and liquid vial manufacturing, the site increases U.S. capacity to manufacture the medicines patients rely on every day.

As part of Thermo Fisher Scientific’s global network, Ridgefield complements our world-class contract development and manufacturing services and strengthens our sterile fill-finish footprint—now spanning seven sites worldwide, including three in the U.S. (Greenville, NC; Plainville, MA; and Ridgefield, NJ). Strategically located along the East Coast to streamline logistics and attract top talent, the 360,000 sq. ft. Ridgefield site plays a vital role in the global pharmaceutical supply chain, with products distributed to more than 67 countries across all continents.

Join Thermo Fisher Scientific and play a critical role in supporting the delivery of life-changing therapies and products to patients worldwide. As a Quality Assurance Validation Manager, you will lead validation activities that ensure product quality, operational excellence, and compliance with global regulatory requirements. Working in a highly collaborative environment, you will partner with Quality Assurance, Manufacturing, Engineering, Regulatory Affairs, and other cross-functional teams to maintain the validated state of systems and processes that support the manufacture of therapeutics and other critical products.

You'll have the opportunity to influence validation strategy, lead complex projects, and develop a high-performing team while contributing to a culture of quality, continuous improvement, and innovation.

As a Quality Assurance Validation Manager, you will provide leadership and oversight for validation programs across equipment, utilities, facilities, computer systems, cleaning processes, analytical instruments, and manufacturing operations. You will ensure validation activities are executed in accordance with cGMP requirements, quality standards, and industry best practices while supporting business objectives, new product introductions, and technology transfer initiatives. In partnership with Quality Assurance and cross-functional teams, you will help maintain compliance and the validated state of critical systems and processes that support the manufacture of therapeutics and other life-changing products.

• Lead and manage validation activities across manufacturing, laboratory, utility, facility, computerized systems, and analytical instruments
• Develop and maintain validation strategies, validation master plans, and project timelines
• Oversee the planning, coordination, execution, review, and approval of validation protocols and reports
• Partner with project managers and cross-functional stakeholders to establish priorities, monitor progress, and communicate project status
• Ensure validation activities comply with FDA, EU, and applicable global regulatory requirements and Quality Assurance standards
• Support equipment qualification, process validation, cleaning validation, utility qualification, computer system validation, and analytical instrument qualification programs
• Apply risk assessment methodologies and statistical tools to support validation decisions
• Drive continuous improvement initiatives to enhance validation processes and operational efficiency
• Manage change control activities and assess validation impacts associated with process or system changes
• Ensure adherence to data integrity requirements and governance standards across validation activities
• Support regulatory inspections, customer audits, and quality assessments
• Mentor, develop, and lead validation professionals while fostering a culture of accountability and excellence

• Advanced Degree with 8+ years of validation experience, or
• Bachelor's Degree with 10+ years of validation experience
• Preferred fields of study include Engineering, Chemistry, Biology, Life Sciences, or related technical disciplines

• Significant experience in validation within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
• Experience coordinating, planning, executing, and approving validation activities across multiple disciplines
• Demonstrated success managing complex validation projects, programs, and teams
• Experience partnering with project managers to establish priorities and drive project execution
• Experience participating in regulatory inspections and customer audits
• Experience with validation master planning, change control systems, and quality management systems
• Expertise in process validation and analytical instrument qualification
• Proficiency in data integrity compliance, governance, and regulatory expectations related to data lifecycle management

• Strong knowledge of cGMP regulations, including FDA, EU, and global regulatory requirements
• Expertise in equipment qualification, process validation, cleaning validation, computer system validation, utility qualification, and analytical instrument qualification
• Strong understanding of ALCOA+ principles, data integrity requirements, and data governance practices
• Proficiency in risk assessment methodologies and statistical analysis
• Strong technical writing, documentation, and report review capabilities
• Excellent leadership, communication, and interpersonal skills
• Ability to influence stakeholders and collaborate effectively across functions and organizational levels
• Knowledge of Lean Manufacturing and continuous improvement methodologies
• Proficiency with Microsoft Office and standard business software applications
• Strong organizational and problem-solving skills with the ability to manage multiple priorities

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards