Senior Engineer, Automation & Data Integrity
Company: Boehringer Ingelheim
Posted on: April 10, 2021
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
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
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, Automation and Data Integrity is responsible
for delivering and maintaining automation-based systems and
solutions which provide for flexible, innovative, cost effective,
compliant and quality-focused manufacturing of Bio-pharmaceuticals.
The incumbent will provide Automation support to the daily
operations, continuous improvement and projects for the Pilot
Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities,
Facilities and other DCS and PLC Automated Equipment and Control
Systems on a GMP regulated environment. The resource will provide
guidance and for data integrity compliance for Automation systems
during projects and improvements implementation. Implements
technical changes to existing control system hardware and software,
and supervises modifications done by outside vendors, including
development of specifications and testing documentation. The Senior
Engineer will participate in a rotating after-hour on call
The candidate will be required to rely on experience and judgment
to plan and accomplish goals with minimal supervision. Experience
in the design, configuration, support and testing of one or more of
the following systems is required\: Delta V DCS, Siemens BMS,
SCADA/PLC control systems and/or OSI PI. Other Automated Control
Systems to be supported includes Simatic and Rockwell HMIs, Cognex
Vision Systems, Sick Sensors, and Serialization (Track and Trace)
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
Duties & Responsibilities\:
- Capital Projects and Automation Projects\:
- Supports Capital Projects by developing, planning and
implementing automation based projects and solutions in
collaboration with cross-functional teams, including determination
and delivery on scope, schedule, cost, and quality to ensure the
sustained production, successful product launches and customer
satisfaction. These projects may be new systems and/or retrofit of
- Provides leadership and/or technical support to projects in
support of the BI Capital Plan.
- Supervise automation consultants, contractors providing
services on the supported areas/projects.
- Supports the qualification of automated systems.
- Manages medium to high complexity projects without
- Acts as a Project Manager for Automation-related projects.
- Acts as Lead for data integrity assessments and implementation
of compliant systems through-out automated areas.
- Provides advanced technical expertise\:
- Performs troubleshooting to the automated equipment. Ensures
effective maintenance and availability of automation
- Execute equipment and control system modifications adhering to
Bio-pharmaceutical GMP change control standards, procedures and
- Create and modify system specifications and standard operating
procedures for the systems supported.
- Train users and peers on control system functionality,
programmable logic controller (PLC), Human Machine Interface (HMI),
computer/control networks, instrumentation and data integrity
- Support software and hardware life cycle management efforts to
maintain systems current and compliant.
- Contributes to developing improved and robust control system
strategies for processes and equipment.
- Performs advanced automation system design that supports data
integrity, stability and interface between different systems.
- Provides documentation, testing, commissioning and validation
support following Good Documentation Practices.
- Implement configuration changes to Historian when required for
- Perform administrative and maintenance tasks for control
- Investigates and analyzes customer opportunities for
improvement. Design, recommends and implements improvement
- Optimization and compliance\:
- Responsible for technical optimization of the automation
- Creation, modification, and maintenance of automation system
and documentation, including automation specification documents and
SOPs, in a compliant state
- Contributes to, supports, and leads BPE/MPE activities to
ensure a continuous optimization process and compliance
- Global Engineering Network for automation and
- Supports definition and implementation of best practice of
automation technical standards and procedures.
- Participates in project and peer reviews.
- Cross-functional liaison\:
- Interfaces with Manufacturing, Process Science, QA, and
Contract Engineering/Vendor firms to develop User Requirements and
Functional Requirements Specifications.
- If required, contributes BIs knowledge to national and
international standard committees (VDI, ISO, ISPE,..) to represent
biopharmaceutical interests and progress.
- Represents automation systems in compliance audits.
- Adheres to safety related company and regulatory standards.
Keywords: Boehringer Ingelheim, Fremont , Senior Engineer, Automation & Data Integrity, Engineering , Fremont, California
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