Validation Director

Simtra BioPharma Solutions•Bloomington, IN

5d•Onsite

About The Position

The Validation Director leads the Validation organization at Simtra BioPharma Solutions’ Bloomington, Indiana facility, a full-service contract manufacturing plant providing formulation, aseptic filling, and finishing services. As a member of the plant senior leadership team, the Director is responsible for Validation functions and reports to the Site Director. The position is onsite five days per week. The organization supports manufacturing operations from Commissioning and Qualification through Performance Qualification. Its teams cover Sterility Assurance Validation, Cleaning Validation, Computer Systems Validation, and Commissioning and Qualification. The role deploys validation strategies that comply with global regulatory requirements and supports new equipment and client drug products, the validated status of facility GMP processes, and representation of Simtra during client and regulatory inspections. The Director oversees validation in a growing manufacturing network, including facilities and filling lines in operation, under commissioning or construction, or planned for future development. The position includes strategic leadership, budget ownership exceeding $10 million, final approval of product and process documentation, and collaboration with site Quality to drive improvements and reduce risk. Global travel may be required at less than 10%.

Requirements

Bachelor’s degree in a technical discipline; preferably in science or engineering.
Minimum 10 years of experience in aseptic manufacturing operations.
Minimum 8 years of experience in Validation.
Minimum 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.

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 the validated status of 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 risk reduction.