Principal Specialist

Boehringer Ingelheim - North America is seeking a highly skilled Principal Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the compliance of our products and processes with regulatory requirements.

The Principal Specialist will be responsible for managing all phases of higher-level, more complex validation project activities at our BIAH location. This includes ensuring GxP regulatory compliance, managing resources, conducting testing, and verifying facilities, utilities, equipment, systems, and processes meet specifications and requirements.

• Manage higher-level, more complex GMP validation project activities from concept through process validation.
• Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition, and upgrade.
• Develop and maintain higher-level departmental and site standard operating procedures (SOP) and training on quality principles.
• Promote staff development and growth, perform training to staff and other departments.
• Lead and actively support strategic direction of validation philosophies, improve overall validation system and process flow incorporating into BIAH VMP.
• Provide oversight and document review for smaller validation projects and routine Validation Maintenance deliverables.
• Develop and maintain local standard operating procedures to follow all FDA/EU/USDA regulations, as well as Corporate procedures.
• Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and/or support continuous improvement.
• 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 with internal, regulatory, or Corporate audits to ensure compliance with domestic and international regulations, quality requirements, and guidance documents.
• Develop and assist with audit responses and completion of assigned CAPAs by target due dates.
• Ensure Validation areas are "inspection ready" at all times.
• Support Change Control, Deviation, and CAPA activities.
• Perform all company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.
• Demonstrate high ethical and professional standards with all business contacts to maintain BIAH's reputation in the community.
• Immediately report noted/observed violations to management.

• Bachelor's Degree in a relevant scientific, bioengineering, or relevant discipline.
• Six (6) years GMP validation or similar experience in a GMP manufacturing or similar production environment.
• Minimum of ten (10) years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degree.
• Experience must be inclusive of at least three (3) years leading projects.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross-functional teams.
• Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
• Excellent written and verbal communication skills.
• Excellence in comprehension/application of 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, such as biology, to apply knowledge or experience to assigned tasks.
• Ability to make decisions regarding the acceptability of product based on documentation provided.
• Demonstrated ability to work with diverse groups of people and conflict management.
• Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint).

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.

You should be proficient in:

• Experience in a Manufacturing Environment.
• Bachelor's Degree.