Boehringer Ingelheim Fremont is therapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit. Weare a fully integrated biologics operation with over 500 scientist andspecialists, covering cutting edge early- to late stage CMC development,clinical and commercial drug substance and drug product manufacturing, medicaldevice assembly for combination products and packaging operations.
We are continuing our rapid growth,investing over %24200m into the expansion of our capacity and capabilities,and creating approximately 200 new jobs.
Driving this growth is an excitingpipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) andbiosimilars, as well as, a growing diverse portfolio of therapeutics we developand manufacture for other leading pharma and biotech companies. This includesmultiple commercial product launches planned over the next couple ofyears, for which we can tap into Boehringer Ingelheim’s unique experience ofhaving brought 30+ biologics to market globally.
Leveraging our diverse talent pool,we are also driving technology and innovation globally, through majorinvestment and collaborations into next generation manufacturing platforms andtechnologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring theirproducts to market or innovate new technologies and approaches - Everything wedo, we do to help patients!#LI-MS1 *I-SF1
This position is responsible for oversight of GMP equipment qualification, which includes introduction of new GMP equipment, modifications to existing equipment, and computer system validation (CSV) in Manufacturing and Quality control. Incumbent provides technical expertise on Quality Assurance standards and processes.Ensures compliance and providing QA oversight of Fremont site equipment qualification according to cGMP regulations for clinical and commercial products.Implements continuous improvement efforts as it relates to equipment activities.
The Specialist Equipment Oversight will be responsible for overseeing the qualification and CSV of new GMP equipment and modifications required for client and internal BI new product introductions (NPIs)and resupplies.
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 amp; Responsibilities:
- Review and approval of equipment qualification and CSV procedures to ensure compliance with cGMP requirements.
- Supports regulatory audits, internal audits and customer audits.
- Participate in audits as SME, prep room staff or Inspection room staff
- Collaboration on responses to any observations
- Oversight and approval of equipment qualification and CSV activities. Review and approval of change controls, protocols, reports, user requirements, CP-11 assessments, recipe specifications, test cases, and Pamp;IDs.
- Identifies, classifies and reports deviations, as appropriate and provides QA oversight of deviations. and CAPAs. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
- Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems.
- Requires a Bachelor’s degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology) or Engineering with five (5) years Quality or Validation experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
- Related work experience executing or overseeing equipment qualification in a cGMP environment
- Experience in Quality systems such as Deviations or Change Control.
- Expertise in Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to equipment qualification in a clinical and commercial environment.
- Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
- Negotiating skills
- Overall understanding of Quality Assurance specifications and process
- Goal setting
- Ability to communicate in an open, customer-focused manner.
- Ability to influence in a team environment and collaborate with peers.
- Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
- Ability to interpret and relate Quality standards for implementation and review to functional areas.
- Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
- High level of personal motivation and initiative, and ability to work independently on projects.
- Attention to detail, safety, quality and customer requirements.
- Proficiency with MS Office products (specifically Word, Outlook, PowerPoint and Excel).
Must be legallyauthorized to work in the United States without restriction.
Must be willing totake a drug test and post-offer physical (if required)
Must be 18 years ofage or older
Who We Are:
At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance.We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture.Learning and development forall employees is key because your growth is our growth.
Want to learn more?Visit boehringer-ingelheim.comand join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer IngelheimPharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim AnimalHealth USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC andBoehringer Ingelheim Fremont, Inc.is an equal opportunity and affirmativeaction employer committed to a culturally diverse workforce.All qualifiedapplicants 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 orexpression; affectional or sexual orientation; pregnancy, childbirth or relatedmedical condition; physical or psychiatric disability; veteran or militarystatus; domestic violence victim status; genetic information (including therefusal to submit to genetic testing) or any other characteristic protected byapplicable federal, state or local law.