Boehringer Ingelheim Specialist, Quality Validation - Process in FREMONT, California
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
This position will be responsible for ensuring process and cleaning validation activities at the site are performed under general supervision using industry best practices that meet or exceed regulatory and compliance requirements. This position will support in ensuring that validation programs are effectively implemented for commercial production of biopharmaceuticals in a multi-product facility.
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:
Under general supervision ensures cleaning and manufacturing processes are validated to required standards. Also provide QA oversight to E&T and ensure equipment/systems remain in a validated state. Administers troubleshooting efforts for protocol discrepancies. Investigates common deviations associated with failures in cleaning or process validations. Applies theory, technical principles, and judgment to address a broad range of difficult projects/problems and reviews complex deviations to management for resolution.
Responsible for developing validation moderate protocols under supervision using a risk-based approach that meets current regulatory requirements and industry practices.
Presents the validation approach and protocol results to peers and management as required. Assists or interacts with regulatory agencies as necessary.
Reviews and interprets data for accuracy of cleaning/process performance for completed validations/re-validations, and prepares report packages by analyzing and summarizing the data to support test and protocol requirements
Successfully manages small to medium cross functional projects to ensure deliverables are met on time.
Reviews and approves controlled documents relating to processes, cleaning, equipment, and computer systems validations.
Quality assurance oversight (as applicable):
Works under general supervision to provide quality assurance oversight of commissioning and qualification activities for adhering to compliance with cGMP’s, regulatory, industry, and corporate requirements. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, providing concurrence on protocol discrepancies, providing quality approval of impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet all requirements. Ensures Quality decisions are made, with consultation from Quality colleagues and management, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
Bachelor's degree from an accredited institution with (5) years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
Master’s degree from an accredited institution with two (2) years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
Excellent technical writing and verbal communication skills
Ability to read/interpret process development and characterization documents
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 ability to manage multiple activities while maintaining a high level of organization.
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 independently manage priorities in alignment with department and site drivers under general supervision.
Ability to interpret and relate Validation standards for implementation and review to functional areas.
Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
Good knowledge of Biopharmaceutical and process engineering.
Leading or managing small to medium technical projects with an interdisciplinary project team, from planning to realization and startup. Good understanding of cGMP guidelines applicable for USFDA.
Good understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
Follows BI OCP, BGS and all applicable procedures.
Participates in inspection preparation activities.
Able to present and defend GMP documentation associated with quality practices.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Fremont
Title: Specialist, Quality Validation - Process
Requisition ID: 187705