Associate Engineer / Engineer/ Senior Engineer, Drug Substance Plant Engineering

at Boehringer Ingelheim
Location Fremont
Date Posted January 14, 2022
Category Engineering
Job Type Full Time


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 Senior Engineer, DS Plant Engineering is an expert in biotechnology manufacturing equipment and process, who will be responsible for leading process equipment readiness in BI Fremont's GMP manufacturing facility for the manufacture of biopharmaceutical drug substance. This includes providing technical expertise for both the operational organization by leading troubleshooting and pro-actively formulating and driving continuous improvements of mechanical and automation functionalities of production equipment, as well contributing to the design elements of new process equipment and modifications to the manufacturing 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:

  • Lead and manage the identification and implementation of new complex manufacturing equipment or modifications to optimize existing processes and ensure achievement of regulatory and safety requirements including driving project requests and providing scope for project initiation.
  • Manage and drive the equipment implementation process and tracks projects status, schedule and identify risks.
  • Oversee the execution, proactively identify risks and collaborate with area owners to resolve issues in the pre-production readiness program with regards to wet run checklists, equipment checklist, tracking the use of assets.
  • Review qualification protocol, provide technical expertise and manage qualification testing to ensure qualification activities meet URS and operational conditions.
  • Lead the equipment readiness within manufacturing including managing the execution testing of the equipment with the appropriate procedures to confirm it will perform as expected in the GMP runs as part of the New Product Introduction process. In addition it includes being present/participating in the initial set up and operation of the equipment in a GMP setting. Responsible for the resolution of issues during testing and initial GMP run.
  • Proactively identify and lead complex technical troubleshooting of mechanical and automation issues. Implement new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
  • Generate process improvement projects deriving from troubleshooting, manages projects list and prioritize projects execution.
  • Drives continuous equipment improvements by optimizing existing equipment with respect to mechanical and automation operability. Collaborate with reliability engineering and manufacturing to reconcile RPN ranking and operational needs to prioritize reliability projects. Responsible for identifying solutions to reliability issues, requesting and leading reliability projects as output of reliability program.
  • Defines equipment-related training programs. This position takes lead on the training program for the department. This position will identify new technical training programs to increase expertise within manufacturing.
  • Design and manage execution at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation. Provide technical assessment of results for studies reports.
  • Determine appropriate CAPA actions based upon deviation investigation. Own and execute CAPAs with regards to process equipment operations and on-going validation.
  • Provide technical input and review for CAPEX projects as user engineers. Lead manufacturing-driven CAPEX projects including project request submission, project scheduling, budget allocations, procurement, qualification and closing out of change controls.
  • Ensures compliance with all manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives.
  • Demonstrates good knowledge of GMP, FDA and European regulations. Follow all relevant department policies, procedures, SOP and other requirements during project execution and act at all times within the BI standards/ethics policies.
  • Participate in BI interactions with various governmental agencies/regulators and external auditors as needed


  • Requires a Bachelors degree from an accredited institution, preferably in a Life Science or Engineering related field with eight (8) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility. Five (5) years of experience as a manufacturing engineer in a GMP environment or clean room assembly environment.
  • In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, preferably in a Science or Engineering related field with a minimum of ten (10) years of experience as a manufacturing engineer in a GMP environment or clean room assembly environment
  • Experienced in qualification principles, GMP guidelines and able to identify risks to equipment functionality as part of qualification.
  • Must be able to demonstrate in-depth understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation.
  • Must have experience leading technical projects in a biotechnology/pharmaceutical environment including ownership of change controls, functional specifications, P&IDs and other controlled documents
  • Able to troubleshoot mechanical/automation issues, identify the root cause, plan corrective actions and implement solutions by cooperating with manufacturing, quality, compliance and automation.
  • Expert understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred.
  • Able to lead RCAs with cross functional team and identify appropriate CAPA for resolution of root cause.
  • Must have strong communication skills to communicate and manage equipment modifications in conjunction with our maintenance staff, automation, validation, compliance and quality.
  • Able to influence Sr. Management to achieve a common goal and overcome obstacles.
  • Strongly desire strong leadership skills and the ability to influence in a team environment and collaborate with peers
  • Subject Matter Expert in Technical Equipment Operations with regard to mechanical and automation operations within manufacturing and has a deep understand of industry trends and technical troubleshooting experience.
  • Expert in validation activities (Mixing and cleaning) and equipment qualification. Independently manage and implement projects as part of Capital Expenditure programs. Proceduralizing safe, cost-effective, and efficient establishment of operational equipment consistent with cGMP regulations. Identify, lead and implement Continues Process Improvements.
  • Expert in understanding compliance and equipment functionality requirements of equipment qualification or re-qualification.
  • Expert with equipment related RCA methodologies, identifying root cause of deviations and generating appropriate technical and non-technical CAPAs.
  • Strong Project Management in a complex manufacturing environment.
  • Has a deep understanding or manufacturing equipment performance and availability and can identify areas of improvement and can collaborate in developing protocols to achieve identified improvements.
  • Evaluates and applies modern operational excellence tools to reduce process variability and steadily deliver measurable efficiency, productivity and/or quality gains.
  • ..... click apply for full job details

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