Principal Validation Compliance Strategist

Join a mission that marries innovation with compliance

At Boehringer Ingelheim, we believe our people are our edge. In this Principal Validation Compliance Strategist role, you’ll safeguard product quality and patient impact by steering sophisticated validation programs—while enjoying a culture that supports well-being, mobility, and global collaboration, along with competitive rewards and benefits.

Your impact

From day one, you’ll be the strategic driver who ensures validation activities meet the highest standards of GxP compliance. You will translate the Validation Master Plan into action across facilities, utilities, systems, equipment, and processes—confirming they perform to specification and are suitable for their intended use.

Key outcomes you’ll deliver

• Govern and execute complex GMP validation projects throughout BIAH US locations in line with VMP and Corporate Policies and Procedures.
• Lead validation work for major capital projects; supervise smaller initiatives and routine Validation Maintenance, including contractor oversight, document reviews, deviations, and CAPAs.
• Plan, sequence, and coordinate testing and resources to maintain compliance with cGMP, FDA, EU, USDA, BIAH, and BI requirements.
• Administer the site validation database and documentation systems; support feasibility assessments and equipment review, selection, acquisition, and upgrades.
• Draft and sustain advanced SOPs; build capability by training staff and cross-functional partners on quality and validation principles.
• Advance validation philosophies and streamline processes; embed improvements into the BIAH VMP.
• Serve on teams focused on change controls, deviations, and technology transfer; bring technical/compliance expertise to resolve issues and drive continuous improvement.
• Partner with Engineering and other groups on system and production equipment decisions.
• Contribute to URS/FRS creation, risk assessments, and DQ for systems and equipment.
• Participate in internal, regulatory, and Corporate audits; craft responses and close CAPAs on time.
• Maintain audit-ready validation areas and support Change Control, Deviation, and CAPA workflows.
• Model exemplary ethics and professionalism; promptly escalate observed violations to management.

Experience and skills

• BS in a scientific, bioengineering, or related field; alternatively, at least ten (10) years of GMP validation experience in a regulated manufacturing environment in lieu of a degree.
• Six (6) years of GMP validation or similar experience within a GMP manufacturing or comparable production environment.
• A minimum of three (3) years leading projects.
• Experienced in organizing, prioritizing, and coordinating multi-threaded project activities.
• Comfortable leading and contributing within cross-functional teams.
• Data-driven approach to assessing GMP compliance and troubleshooting.
• Strong written and spoken communication.
• Expert understanding of FDA/EU/USDA regulations for regulated biological articles.
• Depth in regulated processes and at least one technical domain (e.g., biology) applied to daily work.
• Ability to make product acceptability decisions from documentation.
• Demonstrated success collaborating across diverse groups and managing conflict.
• Proficiency with MS Word, Excel, Outlook, and PowerPoint.

How we operate

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

Take the next step

Grow your career while making a difference for patients, customers, and colleagues in a globally connected organization.

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.