Validation Director

Simtra BioPharma Solutions•Bloomington, IN

6d•Onsite

About The Position

The Validation Director leads the Validation functions at Simtra BioPharma Solutions’ Bloomington, Indiana contract manufacturing plant and is a member of the plant senior leadership team. The role reports to the Site Director and is performed onsite five days per week. The organization supports manufacturing operations from Commissioning and Qualification through Performance Qualification and comprises Sterility Assurance Validation, Cleaning Validation, Computer Systems Validation, and Commissioning and Qualification. The Director deploys validation strategies that comply with global regulatory requirements and oversees the design and validation of processes for new equipment and client drug products, maintenance of validated status for GMP processes, and representation of Simtra in client and regulatory inspections. The position directs development and implementation of processes involving new technologies, owns a budget exceeding $10 million, and has final approval responsibility for product and process documentation, including CAPAs, deviation investigations, and change controls. It also leads strategic planning, execution, and after-action reviews, and collaborates with site Quality to drive improvement and risk reduction. The Bloomington facility provides formulation, aseptic filling, and finishing services. The broader manufacturing network includes operating facilities and additional facilities and production lines in commissioning, construction, or planning. The role may require global travel of less than 10%.

Requirements

Bachelor’s degree in a technical discipline; science or engineering preferred.
At least 10 years of experience in aseptic manufacturing operations.
At least 8 years of experience in Validation.
At least 8 years of technical management experience, including cross-functional teams, resource and budget management, and strategic development.
Strong knowledge of aseptic processing and validation in a globally regulated industry, including FDA, EMEA, PIC/S, and Japan PMDA requirements.
Proficiency with Microsoft Word, Excel, and Outlook, and ability to use quality enterprise software systems.
Ability to meet Grade C gowning requirements.
Duties may require overtime, including nights and weekends.
Global travel may be required, at less than 10%.

Responsibilities

Lead the Validation organization supporting manufacturing operations from Commissioning and Qualification through Performance Qualification.
Deploy validation strategies in compliance with global regulatory requirements.
Oversee validation disciplines responsible for designing and validating processes for new equipment and newly onboarded client drug products.
Maintain validated status for GMP processes throughout the facility.
Represent Simtra in client and regulatory inspections.
Direct the development and implementation of new processes requiring new technologies.
Develop and own a budget exceeding $10 million.
Provide final approval for product and process documentation, including CAPAs, deviation investigations, and change controls.
Lead strategic planning, deployment, execution, and after-action reviews.
Represent the site during regulatory inspections, client visits, and internal audits.
Collaborate with site Quality to drive improvements and reduce risk.