Senior Specialist, Process Validation

Boehringer Ingelheim Fremont , CA 94537

Posted 2 months ago

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.

We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30 biologics to market globally.

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! #LI-MS1 *I-SF1

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.

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

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

'609252

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager (Global Process Owner) Quality Management Systems

Stryker Corporation

Posted 2 weeks ago

VIEW JOBS 10/14/2020 12:00:00 AM 2021-01-12T00:00 Job Description What we want: * Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner. * Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success. * Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration. What you will do As a Senior Manager (Global Process Owner), Quality Management Systems you will be responsible for setting the direction for our company-wide practices and processes for Change Management and other assigned Quality System elements. You will lead the architecture, planning, management and implementation of said systems. You will be the company's subject matter expert and, therefore, represents Stryker in the most important industry groups and with global regulatory agencies to influence industry practice and to ensure Stryker is fully in compliance with global practices, regulations, and standards. You will also select, develop, and guide the Division Process Owners for instilling the company-wide processes at each design division and location. Change Management & Quality System Process Responsibility. * You will collaborate with Corporate, Division, and Global Quality & Operations leaders and other key business partners on the ongoing design and enhancement of company-wide processes, including harmonization/standardization and alignment across connected and adjacent systems. * You will provide strategic direction and oversight for assigned Quality Systems processes to ensure adherence to and compliance with all applicable regulations. * You will define and use standardized global process metrics to monitor and act in assigned areas of Quality System responsibility. * You will also help to select, develop, and guide the Division Process Owners for instilling the company-wide processes at each design division and location. * You should be able to leverage your SME status and influence input for the Global Quality Manual, QMS planning, and company-wide Management Review processes. * You will lead company-wide processes and requirements for assessment of the effectiveness of the Quality System elements. * You will be a lead expert for assessment of M&A targets, integrations, and post-integration remediation actions as it relates to these Quality System elements. * You will provide leadership and guidance for the back room with FDA inspections and other audit readiness activities in assigned area of Quality System responsibility for organizations within Stryker as appropriate. * You will mentor and develop associates supporting assigned area of Quality System responsibility. What you need * Bachelor's degree in Life Sciences, Engineering, Quality, or related technical field * Minimum of 12 years' experience with Quality Systems, medical device manufacturing, or related field required. * Location can be flexible and based near/out of any Stryker site. Preferred Qualifications * Experience in leading and/or managing teams and/or project teams highly preferred. * Master's degree preferred * Extensive experience in designing and implementing Quality System processes in support of devices governed by the FDA, ISO, and other regulatory authorities preferred. * Experience in developing, implementing, and/or improving Quality System processes, procedures, and/or electronics systems required preferred. * Experience in multi-divisional program/project design leadership strongly preferred. * Experience implementing company-wide initiatives preferred. * Proven abilities to successfully interact with the highest levels of leadership, up to the SLT. Work From Home: Occasional Travel Percentage: 30% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Job Requirements Stryker Corporation Fremont CA

Senior Specialist, Process Validation

Boehringer Ingelheim