Description

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.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

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.

Requirements

Requires a Bachelors degree from an accredited institution, preferably in a life science or engineering related field, with six (6) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility, plus a minimum of two (2) 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 (8) 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.
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

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.