Short Description

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 several 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.

The Associate Engineer, DS Plant Engineering assists in ensuring process equipment readiness in BI Fremonts GMP manufacturing facility for the manufacture of biopharmaceutical drug substance. This includes troubleshooting and identifying potential improvements in mechanical and automation functionalities of production equipment. 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 Ingelheims high regard for our employees.

The Engineer, DS Plant Engineering is responsible for ensuring process equipment readiness in BI Fremont's GMP manufacturing facility for the manufacture of biopharmaceutical drug substance. This includes providing technical expertise for the operational organization by troubleshooting and driving continuous improvements of mechanical and automation functionalities of production equipment. The position designs and defines the pre-production readiness test program (wet run program, automation change verification and equipment modification) and technical training program in collaboration with the supporting functions. The position provides technical expertise for the design of new process equipment and modifications to the manufacturing facility. 

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.

Duties & Responsibilities:

Associate Engineer

• Assists in the identification and implementation of new manufacturing equipment or modifications to optimize existing processes and ensure achievement of regulatory and safety requirements. Assists with the pre-production readiness program with regard to wet run checklists, equipment checklist, tracking the use of assets in collaboration with area owners. Coordinates equipment readiness within manufacturing. Activities include the 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.
• Assists with technical troubleshooting of mechanical and automation issues. Implement new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
• Assists with equipment-related training programs.
• Perform at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
• Own and execute CAPAs with regard to process equipment operations and on-going validation.
• Provide technical input and review for CAPEX projects as user engineers.
• 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.

Duties & Responsibilities:

Engineer, DS Plant Engineering

Identify and scope equipment modifications for continuous operations and reliability improvement.
Provides technical expertise for new equipment start up and qualification activities.
Activities include executing wet testing new or modified equipment in accordance to the URS and FS. Participate in the initial set up and operation of the equipment post GMP release.
Lead technical troubleshooting of mechanical and automation issues. Identify and implement solutions to increase reliability and availability of assigned process equipment.
Collaborate with manufacturing, quality and technical groups to seek innovative solutions to technical issues.
Defines equipment-related training programs.
Execute at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
Own and execute CAPAs for process equipment.
Provide technical input and review for CAPEX projects as user engineers.

Duties & Responsibilities:

Senior Engineer, DS Plant Engineering

Leads and manages 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.
Manages and drives the equipment implementation process and tracks projects status, schedule and identify risks.
Oversees the execution, proactively identifies risks, and collaborates 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.
Reviews qualification protocol, provides technical expertise, and manages qualification testing to ensure qualification activities meet URS and operational conditions.
Leads 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 identifies and leads complex technical troubleshooting of mechanical and automation issues.
Implements new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
Generates 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.
Collaborates 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.
Takes lead on the training program for the department.
Identifies new technical training programs to increase expertise within manufacturing.
Designs and manages execution at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
Provides technical assessment of results for studies reports.
Determines appropriate CAPA actions based upon deviation investigation.
Owns and executes CAPAs with regards to process equipment operations and on-going validation.
Provides technical input and review for CAPEX projects as user engineers.
Leads manufacturing-driven CAPEX projects including project request submission, project scheduling, budget allocations, procurement, qualification and closing out of change controls.

Requirements:

Engineer, DS Plant Engineering

• Requires a Bachelors degree from an accredited institution, preferably in a life science or engineering related field, with six (5) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility, plus a minimum of two (1) 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 eight (5) years of experience in a GMP environment or clean room assembly environment, plus a minimum of two (2) years of experience as a manufacturing engineer in a GMP environment or clean room assembly.
• In lieu of degree, will consider High School Diploma plus 7 years of related field experience with (3) years manufacturing or engineering
• Will consider Master Degree with 0-1 year GMP experience, Plus a minimum of 1 years experience as a engineer in a GMP environment or clean room assembly environment.
• Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement.
• Experience with equipment qualification or re-qualification.
• Experience with equipment related RCA within Deviations and CAPAs.
• Experienced in Technical Equipment Operations within manufacturing and has an understanding of industry trends and technical troubleshooting experience.
• Awareness in validation activities (Mixing and cleaning) and equipment qualification.
• Experience in Managing and implementing Capital Expenditure programs.
• Must be able to demonstrate basic understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation.
• Understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred.
• Must have strong communication skills to communicate and oversee equipment modifications in conjunction with our maintenance staff.
• Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.
• Projects are cross functional and the project scope is limited. Should be able to independently influence peers to achieve a common goal.
• Be able to multi-task and be organized.
• Awareness of proceduralizing safe, cost-effective, and efficient establishment of operational equipment consistent with cGMP regulations.
• Has an understanding or manufacturing equipment performance and availability and can identify areas of improvement and can collaborate in developing protocols to achieve identified improvements.
• Basic understanding of mammalian based biopharmaceutical manufacturing processes, knowledge of regulatory aspects of cGMP.

Compensation Data

Engineer, DS Plant Engineering

This position offers a base salary typically between (112,000) and (193,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

Eligibility Requirements: