Principal Specialist, Validation

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Principal Specialist, Validation – Boehringer Ingelheim – Athens, GA

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunities for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company’s success. We support our employees through a healthy working environment, mobility, networking, and work‑life balance. Our competitive compensation and benefit programs reflect our high regard for our employees.

• Lead higher level, more complex GMP validation project activities at the BIAH US locations from concept through process validation as outlined by BIAH’s Validation Master Plan (VMP) and Corporate Policies and Procedures.
• Maintain the site validation database and document systems; support feasibility studies, equipment review, selection, acquisition and upgrade.
• Develop and maintain departmental and site standard operating procedures (SOPs) and train staff on quality principles.
• Promote staff development and growth, performing training for staff and other departments.
• Lead and actively support strategic direction of validation philosophies, improving overall validation system and process flow incorporating into BIAH VMP.
• Oversee smaller validation projects and routine Validation Maintenance deliverables, including document review.
• Develop and maintain local SOPs to follow FDA/EU/USDA regulations and Corporate procedures.
• Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource.
• Train personnel in quality and validation principles.
• Support Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment.
• Provide technical support in developing user and functional requirements specifications, URS, RA FRS, and DQ for systems and equipment.
• Participate in internal, regulatory, or Corporate audits to ensure compliance and develop audit responses and CAPA completion.
• Ensure Validation areas are “inspection ready” at all times.
• Support Change Control, Deviation and CAPA activities.
• Perform all company business in accordance with regulations (e.g., EEO, FDA) and Company policies.
• Demonstrate high ethical and professional standards with all business contacts to maintain the company’s reputation.
• Immediately report observed violations to management.

• Bachelor’s degree in a relevant scientific, bioengineering, or related discipline.
• Six (6) years of GMP validation or similar experience in a GMP manufacturing or similar production environment.
• Ten (10) years of GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
• Inclusive experience of at least three (3) years leading projects.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Leadership skills and ability to work within cross‑functional teams.
• Analytical skills to assess compliance with GMP requirements through validation and production data.
• Excellent written and verbal communication skills.
• Proficiency in FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
• Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
• Decision‑making ability regarding product acceptability based on documentation.
• Ability to work with diverse groups and manage conflict.
• Skillful use of office applications (MS‑Word, MS‑Excel, MS‑Outlook, PowerPoint).

• Legally authorized to work in the United States without restriction.
• Willing to undergo a drug test and post‑offer physical examination (if required).
• 18 years of age or older.

• Our Company

With us, you can develop your own path in a company that values diverse strengths and strives to make lives better. Your development is a priority, and you’ll work in a respectful, friendly environment where all are valued. We invest heavily in health, wellbeing, and global accessibility to healthcare, enabling you to transform lives for generations.

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