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Engineer/Senior Engineer, Automation & Data Integrity

Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 19, 2021

Job Description:

Description:

Engineer/Senior Engineer, Automation & Data Integrity

The qualified candidate will be hired at the appropriate level commensurate with education/experience.

 

 

Senior Engineer 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.

 

Engineer Description\:

 

The Engineer, Automation is responsible for delivering and maintaining automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused manufacturing of Biopharmaceuticals.

 

The incumbent will provide Automation support to the daily operations and continuous improvement 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. Other responsibilities include implementation of technical changes to existing control system hardware and software, supervision of modifications done by outside vendors, including development of specifications and testing documentation, and participation in Capital equipment and automation projects projects with guidance from project leads.  The Engineer will participate in a rotating after-hour on call program.

 

Experience in the 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.

 

 

 

 

Senior Engineer 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.

 

 

 

 

Engineer Duties & Responsibilities\:

  • Automation Projects and CapEx\:
  • Participates and executes automation based projects and solutions in collaboration with cross-functional teams, including determination and delivery on cost, time and quality to ensure the sustained production, successful product launches and customer satisfaction. These projects may be new facilities and/or retrofit of existing.
  • Supports the validation of automation systems with the qualification and validation functions
  • Provides technical support to projects in support of the BI Capital Plan.
  • Provides technical expertise\:
  • Automation technical knowledge for troubleshooting, investigations and training.
  • Automation system hardware and software support, including installation.
  • Automation system design for data integrity, stability and interface between different systems
  • Ensuring effective maintenance and availability of automation equipment
  • Implementing automation changes to existing control system hardware and software, supervising hardware and software modifications done by outside vendors, and development of specifications and testing documentation.
  • 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
  • Global Engineering Network for automation and standardization\:
  • Utilizes best practices of automation technical standards and  procedures locally.
  • Participates in project reviews
  • Cross-functional liaison\:
  • Interfaces with Manufacturing, Process Science, QA, and Contract Engineering/Vendor firms to develop User Requirements and Functional Requirements Specifications.
  • Adheres to safety related company and regulatory standards.

 

Senior Engineer 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.

 

 

Engineer Requirements\:

  • Bachelors Degree from an accredited institution in Science or Engineering, preferably computer Science, Chemical, Mechanical, or Electrical Engineering, is required.
  • At least three (3) years of relevant work experience. 
  • Subject matter expert in the implementation and support of automation systems.
  • Working knowledge of the process equipment, instrumentation, and/or computerized systems typically applied to biopharmaceutical manufacturing processes.
  • General understanding of functions supporting biopharmaceutical or other high-tech manufacturing.
  • Ability to effectively participate with cross-functional teams in the implementation of sustainable automation solutions.
  • Experience in a regulated manufacturing environment, preferably pharmaceuticals.
  • 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 effectively collaborate in multidisciplinary project groups and deal with customers and suppliers.
  • Good understanding of legal and regulatory aspects within biopharmaceutical business and EHS.

 

Eligibility Requirements\:

 

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

 

Who We Are\:

 

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.


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

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