Sr. Manager, Validations

What You Will Achieve

Reporting to Site Technical Services Lead, this position is responsible for leading the site Validation organization supporting a continuous 24/7 aseptic manufacturing operations. The incumbent will provide strategic and operational leadership for teams responsible for Process Validation, Cleaning Validation, Aseptic Process Simulations (APS/media fills), Aseptic Process and Equipment Qualifications, Utility Qualifications, Facility and CTU qualifications, Smoke Studies, and Periodic Requalification programs.

This role serves as the site Subject Matter Expert (SME) for Validation and Qualification programs and is the principal point of contact for regulatory agency interactions related to validation strategy, execution, and lifecycle management.

The Senior Manager, Validation is accountable for building, developing, and leading a large, diverse organization of engineering professionals and managers responsible for the development, implementation, and maintenance of compliant validation systems that support safe, reliable, and compliant commercial supply.

Where appropriate, this role advises site leadership and operational teams on validation strategy, implementation of changes, and lifecycle management expectations, and provides training, tools, and governance to ensure sustained compliance and inspection readiness.

Accountable for activities involved in the evaluation, review and approval of the validation master plan, validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements, investigating/troubleshooting validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies, and writing, reviewing, approving and/or implementing documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.

How You Will Achieve It

Provide strategic leadership and oversight for all site validation and qualification activities, including:

o   Process Validation and Continued Process Verification

o   Cleaning Validation

o   Aseptic Process Simulations

o   Equipment Qualification

o   Utility Qualification

o   Facility and CTU qualification

o   Smoke Studies and airflow visualization

o   Periodic Review and Requalification programs

·       Serve as the site SME for Validation, leading regulatory interactions and representing site validation programs during FDA and global regulatory inspections.

·       Lead and manage a large, technically diverse organization of validation engineers, managers, and contractors; establish clear expectations, provide coaching and development, and build a strong culture of ownership, engagement, and accountability.

·       Establish and maintain robust validation lifecycle strategies, ensuring alignment with global PQS expectations, regulatory requirements, and industry best practices.

·       Provide governance and oversight for capital improvement projects, new installations, and process changes requiring qualification and/or validation.

·       Ensure validation activities are appropriately risk-based and aligned with regulatory expectations, including aseptic processing requirements and Annex 1 principles.

·       Partner closely with Operations, Engineering, Technical Services, Quality Compliance, Regulatory Affairs, and Automation to ensure integrated execution of validation activities.

·       Advise site leadership on evolving regulatory expectations, network standards, and industry trends impacting validation and aseptic processing.

·       Ensure validation documentation, data integrity, and lifecycle management practices support sustained inspection readiness

Here Is What You Need (Basic Requirements)

• Applicant must have bachelor's degree and 6+ years of relevant experience; OR a master's degree and 5+ years of relevant experience; OR a PHD with 1+ years of experience.

• Strong technical expertise in GMP validation and qualification within aseptic pharmaceutical manufactu