Senior Validation Governance Lead

Shape the validation landscape at Boehringer Ingelheim

Do you thrive on bringing order to complex validation programs? Can you steer cross-functional teams, guide documentation quality, and keep a site audit-ready—every day? If so, you’ll feel at home at Boehringer Ingelheim Animal Health, where global collaboration, career mobility, and meaningful work come together. We back your impact with competitive pay, comprehensive benefits, and a culture that prioritizes people.

What you’ll lead

• End-to-end ownership of advanced GMP validation projects across BIAH US sites, in alignment with the Validation Master Plan (VMP) and Corporate Policies.
• Program management for validation scopes within major capital projects; governance and review for smaller department initiatives, including contractor oversight, deviation handling, and CAPA assessments.
• Scheduling and coordination of testing to verify that facilities, utilities, equipment, systems, and processes meet specifications and are fit for purpose.
• Site validation database stewardship and document system management; contributions to feasibility studies and equipment selection, acquisition, and upgrades.
• Definition and maintenance of advanced SOPs; delivery of training to embed quality and validation principles across teams.
• Leadership of validation philosophy and process-flow improvements, integrating enhancements into the BIAH VMP.
• Oversight of routine Validation Maintenance deliverables and documentation reviews.
• Development and maintenance of local procedures aligned with FDA/EU/USDA regulations and Corporate standards.
• Participation on internal/external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to resolve quality issues and drive continuous improvement.
• Support to Engineering and partner departments on system and production equipment selection, review, acquisition, and upgrades.
• Technical input into URS/FRS, risk assessments, and design qualification (DQ) for systems/equipment.
• Involvement in internal, regulatory, and Corporate audits; preparation of responses and timely closure of CAPAs.
• Maintaining an inspection-ready validation environment; supporting Change Control, Deviation, and CAPA processes.
• Upholding high ethical and professional standards; promptly reporting observed violations to management.

What makes you successful

• BS in a scientific, bioengineering, or related field; or ten (10)+ years of GMP validation experience in a regulated manufacturing environment in lieu of a degree.
• Six (6)+ years of GMP validation or equivalent experience in a GMP production setting.
• Three (3)+ years leading projects.
• Demonstrated strength in project planning, prioritization, and coordination.
• Experience leading cross-functional teams.
• Ability to analyze validation/production data for GMP compliance and troubleshoot issues.
• Exceptional written and verbal communication.
• Mastery of FDA/EU/USDA requirements governing regulated biological products.
• Applied knowledge of regulated processes and at least one technical discipline (e.g., biology).
• Judgment to determine product acceptability from documentation.
• Comfort working with diverse groups; skilled in conflict resolution.
• Fluent with MS Word, Excel, Outlook, and PowerPoint.

Compliance matters

Performs all company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.

Ready to apply?

Join a company that recognizes your expertise and invests in your growth.

Eligibility Requirements

:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.