Senior Specialist, Process Validation at Boehringer Ingelheim Pharmaceuticals, Inc in Fremont, CA

Description:

This position is responsible for performing a wide range of process validation activities under minimal supervision as per applicable company procedures and regulatory guidance. Responsibilities may include, but are not limited to, leading and supporting PPQs, resin and membrane lifetime studies, CPV, mixing studies, media fills, and other projects.

Applies project management skills and concepts to lead projects of a moderate level of complexity with an interdisciplinary project team from planning stage to project completion. In addition they may present process validation topics during regulatory and customer audits.

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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

• Responsible for recommending validation strategy, leading the generation, execution and reporting of process validation deliverables and supporting documentation using a risk-based approach.
• Conduct risk assessments and validation impact assessments.
• Represent Process Validation in project teams for both client and internal products.
• Represent the company in client-facing meetings.
• Communicate clearly and effectively and escalate concerns as needed.
• Manage medium cross-functional projects to ensure deliverables are completed on time and to a high level of quality.
• Lead and participate in inspection readiness activities.
• Present validation packages and programs at regulatory inspections and client audits.
• Support deviation investigation activities and perform validation impact assessments.
• Mentor and support junior staff by providing guidance in decision making, determining validation strategy, authoring complex documents and executions.
• Follows company site and global procedures.
• Participates in inspections and inspection readiness activities.

Requirements:

• Bachelor's Degree from an accredited institution in Life Sciences or Engineering, with seven (7) years of pharmaceutical Quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
• Masters Degree from an accredited institution in Life Sciences or Engineering, with four (4) years of pharmaceutical quality experience and two (2) years of Validation Lifecycle Approach experience in Cleaning or Process Validation (e.g. ASTM E2500, GAMP).
• Excellent technical writing and verbal communication skills
• Experience in reading and interpreting process development and characterization documents
• Experience in interpreting and relating Validation standards for implementation and review to functional areas.
• Demonstrate experience in the application of small-scale versus production-scale process validation.
• Experience in bulk manufacturing processes (e.g. continuous or batch cell culture process and purification process) and drug production aseptic filling process and associated regulatory requirements.
• Experience in managing technical projects with an interdisciplinary project team, from planning to realization and start up.
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
• Demonstrated experience managing multiple activities while maintaining a high level of organization.
• Must have a experience in the application of validation principles.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
• Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
• Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
• Good knowledge and skills in Biopharmaceutical and process engineering.
• The incumbent is expected to perform risk assessments, critical decision making and problem solving, work independently with supervision, and know when to escalate issues or problems for resolution, and provide compliant solutions for validations.
• Excellent understanding of validation principles in pharmaceutical / biopharmaceutical / medical device industries.
• Participates in deviation investigations and provides validation impact assessment.
• Excellent problem solving skills, communication skills, and commitment to a risk-based approach.
• Quality mindset required.
• Motivated and proactive team player.
• Good understanding of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
• Able to present and defend validation documentation and procedures to regulatory agencies and clients.