Boehringer Ingelheim Engineer, Equipment 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.
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!
The Equipment Engineer acts as an Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems. This includes but not limited to Upstream and Downstream BDS, Filling and Packaging equipment. Serve as a Primary Point of Contact to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover. May also own change control and participate in deviation/risk assessment activities. Manage small in size and complexity equipment related projects. May be expected to act a System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
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.
Experience withprocess systems and equipment within the following areas: Bioreactors,Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP,Filling and Packaging equipment. Knowledge about the processes, automation andequipment-specific technology to participate in troubleshooting as theEngineering technical lead. Technical Analysis: including process system and technology plant fits, capacity andequipment utilization, value engineering, sustainable design, constructabilityand assessment of applicable new technologies to balance performance, cost andmaintainability.
Lead/participate inCAPEX/OPEX/CI projects
Provide riskassessment for new systems and changes to existing systems
Write simple projectexecution plans
Executestartup/commissioning activities (e.g. write commissioning report,review/approve TOPs, create/update/review/approve SOPs...)
Technical reviews ofprotocols and periodic monitoring
Lead or participatein project team including the supervision of contractors
Provides estimatesof resource requirements.
Contributes to thetechnical optimization of the field of care
Works with SeniorEngineers to ensure the Process/Manufacturing equipment, machinery,documentation and technical support meets the compliance, quality and EHSstandards.
Contributes to andsupports BPE/MPE activities to ensure a continuous optimization process.
Assist with CAPA,deviation, change control, and risk assessment (quality, business and/or safety)for activities up-to initial qualification/handover.
Supportsimplementation and improvement of best practice of technical standards,procedures.
May participate inpeer to peer reviews.
Bachelors degreefrom an accredited institution in Engineering plus five (5) years of relatedfield experience, or
Master degree froman accredited institution in Engineering plus three (3) years of related fieldexperience
Minimum of two (2)years working experience in a GMP manufacturing environment
Basic hands onexperience with process system/equipment in DS and DP areas
Basic knowledge ofcommercial/clinical manufacturing and warehouse operations
Basic knowledge ofrisk assessment, root cause investigation, projectstartup/commissioning/qualification
Experience withtroubleshooting technical issues
Understandcompliance requirement on change control, deviation and CAPA
Basic knowledge inGMP manufacturing site
Basic knowledge ofprocess equipment/system
Safety awareness inmanufacturing environment
Basic equipmenthands on experience
Physicaldemands/surroundings - works primarilyin an office environment. Required to beon the process floor as necessary to perform work outlined in thisprofile. Some domestic and internationaltravel may be required
Visual Demands - must be able to read and see clearly withor without correction lens
Attendance/schedule - attendance requirements are based ongeneral attendance policies and the needs of the business as set forth bydirect manager
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 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 at http://www.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.
Organization: US-BI Fremont
Title: Engineer, Equipment
Other Locations: Americas-US-CA-San Francisco
Requisition ID: 2013609