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AD, Process & Cleaning Validation, Fremont CA

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 a number of 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.

The Associate Director, Process and Cleaning Validation leads the combined Process Validation and Cleaning Validation programs for US BioPharma's multi-product Drug Substance and Drug Product manufacturing facilities. This role provides strategic oversight and technical leadership for validation activities throughout the product lifecycle — from new product introduction (NPI), clinical, PPQ, and commercial manufacturing, through ongoing lifecycle management, periodic review, and revalidation. The position ensures robust, compliant, and efficient validation processes, drives continuous improvement, and maintains audit readiness, while collaborating cross-functionally to support site and corporate objectives.

Duties & Responsibilities

Validation Program Leadership

  • Owns and governs the Process Validation, Cleaning Validation, Cleaning Verification, Clean Hold, Control Strategy, Media Fill, Transport Validation, Continuous Process Verification, and Revalidation programs for the Fremont site
  • Develops and implements validation strategies in alignment with global teams, regulatory expectations, and industry best practices
  • Coordinates cross-functional efforts to plan, prepare and execute Process Performance Qualifications (PPQs). Manages resources and ensure timely completion of deliverables for PPQ & BLA
  • Accountable for US BioPharma's Control Strategy and Continued Process Verification programs from PPQ through product life cycle.  Responsible for coordinating cross-functional revision efforts and maintaining the program in an audit ready state
  • Maintains validation programs and documentation in an audit-ready state, ensuring successful outcomes during health authority inspections, corporate audits, and client audits

Technical Oversight

  • Leads risk assessments, cycle development, stage gate management, protocol preparation and execution, verification, and periodic review for both process and cleaning validation
  • Ensures validation lifecycle management of manufacturing processes, including trending, gap closure, and continuous improvement hroughout the commercial production of Boehringer internal and client products
  • Champions simplification and optimization projects to increase compliance and efficiency.

Cross-Functional Collaboration & People Leadership

  • Works closely with Engineering, Technology, Manufacturing, CPT, Quality, and Compliance to troubleshoot and resolve validation challenges, investigate deviations, and drive improvements
  • Leads and supports cross-functional project teams for new product introductions and program improvements
  • Manages and develops a team of validation SMEs and staff, providing coaching, technical guidance, performance management, and career development
    •Implements resource planning tools to project staffing needs and manage costs

Audit Readiness and Regulatory Representation

  • Develops audit strategies and represents the site in client and regulatory agency meetings, defending validation programs and outcomes
  • Participates in interactions with governmental agencies/regulators, external auditors and clients

Requirements

  • Bachelor’s degree in Life Sciences, Chemical Engineering, Biotechnology, Biochemical Engineering, Biomedical Engineering, Biology, Chemistry, or related field. Master’s or PhD preferred
  • 8+ years (Bachelor’s) or 6+ years (Master’s) in pharmaceutical industry with direct cGMP experience; 2+ years managing/directing people or projects (Cleaning Validation)
  • Experience in interpreting and implementing validation standards across functional areas. Proven ability in applying creative methodologies that are compliant with regulatory expectations
  • Independent decision-making, ability to think conceptually and understand impact of decisions critical to product quality
  • Demonstrate initiative and flexibility in problem solving, providing risk-based solutions
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes
  • Ability to work as part of high performing teams, collaborate effectively with staff at all levels, and establish highly functional relationships with diverse internal and external stakeholders
  • Advanced knowledge of cGMP, regulatory compliance, and validation standards
  • Excellent verbal and written communication skills; strong interpersonal skills
  • Lean/Six Sigma or business process excellence experience preferred

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

Compensation Data

This position offers a base salary typically between ($140,000) and ($222,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  Please reach out Talent Acquisition or your HR Business Partner for more information.  

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