SR Principal Specialist, Validation

Description

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 opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Leveraging at the highest degree of technical expertise, leadership skills, and a deep understanding of GXP regulatory requirements in a manufacturing environment, the Senior Principal Specialist, Validation is responsible for overseeing the most complex validation processes, projects, systems, and equipment. The incumbent manages all phases of validation project activities including concept through final validation in alignment with GxP regulatory compliance, Validation Master Plan (MVP), and Corporate Policies and Procedures. Key responsibilities for this role include, but are not limited to, leading/coaching assigned direct reports and providing day-to-day direction; ensuring all validation activities are conducted in accordance with cGMP, FDA, EU, USDA and other applicable regulatory requirements and company standards; overseeing the validation of processes, systems, and equipment, ensuring they meet the necessary quality standards; ensuring all validation activities comply with relevant regulatory standards; contribute to strategic planning and decision-making at the senior management level to develop and implement validation strategies and plans; and promoting a culture of continuous improvement within the validation team, identifying opportunities for process and efficiency improvements.

Duties & Responsibilities

• Responsible for managing major validation topics as outlined in the Validation Master Plan (VMP) and Corporate Policies and Procedures.
• Drives validation scheduling resources, testing, and facilities verification and ensures utilities, equipment, systems, and processes meet specifications and requirements and are suitable for their intended purposes.
• Oversees the site validation database and document systems, support feasibility studies, equipment review, selection, acquisition, and upgrade.
• Develops and maintains critical SOPs and training on quality principles.  
• Leads and actively supports strategic direction of validation philosophies and core validation topics (i.e. Process Validation, Cleaning Validation).
• Delivers improved validation system and process flow incorporating into VMP.
• Leads document review for complex/critical validation projects and validation maintenance deliverables.
• Develops, maintains, and trains on SOPs ensuring compliance with all FDA/EU/USDA regulations and corporate procedures.
• Responsible for departmental and cross-functional communication to stakeholders/management on validation topics, projects, activities, etc.  Identifies and develops improvements for the Validation processes.
• Serves as the site SME for assigned internal and external project teams (change controls, deviations, technology transfer) in support of solving quality related issues and/or support continuous improvement in the core topic area.
• Trains applicable personnel in quality and validation principles.
• Leverages industry experience to support Quality Control and Production in the creation of new or transfer of production or cleaning processes.
• Provides technical support in developing specifications (CSS or cleaning matrices) for new processes (cleaning/product).
• Shares quality philosophies throughout Production/Operations.
• Leads internal, regulatory, or corporate audits ensuring compliance with domestic and international regulations, quality requirements and guidance documents inclusive of leading cross-functional teams. 
• Leads audit responses and completion of assigned CAPAs and action items resulting from inspections. 
• Responsible for ensuring Validation areas are always “inspection ready”.
• Leads Change Control, Deviation and CAPA activities.  
• Provides day-to-day direction in managing direct reports, contractor oversight, document review, deviation management and CAPA assessment, as applicable.
• Provides department review/approval to routine validation documents.
• Serves as a subject matter expert for internal and external department/site and global topics related the specific validation topic.
• Responsible for prioritizing workload for validation activities, and communicates priorities to direct reports, to avoid delays in Production or final product shipment.
• Identifies and develops improvements for the Validation processes.

Requirements

• Bachelor Degree in a relevant scientific, bioengineering, or relevant discipline
• Minimum of ten (10) years leading/managing moderate to complex validation or relatable GXP activities/projects within a cGMP manufacturing or similar operations environment.
• Experience must be inclusive of at least five (5) years leading people or moderate to complex projects.
• Understanding of GMP and compliance requirements, Outlines of Production and 9 CFR knowledge to assess product, procedures, recommend improvements and make correct decisions. 
• Ability to utilize computer programs such as Microsoft suite, SAP, Veeva Vault, Learning One Source and other relevant electronic applications.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross function 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) and generating reports.

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.

Desired Skills, Experience and Abilities