Senior Engineer, Automation & Data Integrity

Company: Boehringer Ingelheim
Location: Fremont
Posted on: April 10, 2021

Job Description:

Description:
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!

Description\:

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 program.

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) systems.

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\:

• 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 existing.
• 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 assistance.
• 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 equipment.
• Execute equipment and control system modifications adhering to Bio-pharmaceutical GMP change control standards, procedures and policies.
• 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 concepts.
• 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 equipment/instrumentation/data addition.
• Perform administrative and maintenance tasks for control systems.
• Investigates and analyzes customer opportunities for improvement. Design, recommends and implements improvement suggestions.
• Optimization and compliance\:
• Responsible for technical optimization of the automation systems
• 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 standardization\:
• 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. Requirements\:
  
  
  • Associate Degree from an accredited institution in Science or Engineering, preferably computer Science, Chemical, Mechanical, or Electrical Engineering, plus eleven (11) years of relevant work experience, six (6) years of project leadership, four (4) years of GMP experience, ten (10) years of Automation experience; Or
  • Bachelors from an accredited institution, plus six (6) years of relevant work experience, two (2) years of project leadership experience, four (4) years of GMP experience, five (5) years of automation experience required; Or
  • Masters from an accredited institution, plus four (4) years of relevant work experience, two (2) years of project leadership experience, four (4) years of GMP experience, five (5) years of automation experience required; Or
  • High School Diploma, plus thirteen (13) years of relevant work experience, eight (8) years of project leadership experience, four (4) years of GMP experience, twelve (12) years of Automation experience.
  • Subject matter expert in the design, implementation, and support of automation systems.
  • General understanding of functions supporting biopharmaceutical or other high-tech manufacturing.
  • Ability to effectively lead cross-functional teams in the implementation of sustainable automation solutions.
  • Experience in a regulated manufacturing environment, preferably pharmaceuticals.
  • Working knowledge of the process equipment, instrumentation, and/or computerized systems typically applied to Bio-pharmaceutical manufacturing processes
  • Knowledge and experience with compliance applied to automated systems, including Data Integrity compliance assessing, implementation, testing, and reporting.
  • Detail-oriented, with excellent written and verbal communication skills
  • Strong technical writing and presentation skills
  • Ability to be flexible and manage change
  • Ability to communicate and collaborate with technical and management staff
  • Ability to work independently and collaboratively
  • Strong analytical skills to identify potential improvement opportunities, and drive to opportunities to realization
  • Good knowledge of economic relations and business needs.
  • Ability to lead multidisciplinary project groups and deal with customers and suppliers.
  • Good understanding of legal and regulatory aspects within biopharmaceutical business and EHS. Eligibility Requirements\:
    
    
    ..... click apply for full job details

Keywords: Boehringer Ingelheim, Fremont , Senior Engineer, Automation & Data Integrity, Engineering , Fremont, California