The Senior 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, 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. 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.
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 Biopharmaceutical 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, and instrumentation).
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
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
Interfaces with Manufacturing, Process Science, QA, and Contract Engineering/Vendor firms to develop User Requirements and Functional Requirements Specifications.
Bachelor’s Degree in Science or Engineering, preferably computer Science, Chemical, Mechanical, or Electrical Engineering, from an accredited university or college required plus eight (8) years of relevant work experience, four (4) years of project leadership experience, four (4) years of GMP experience, five (5) years of automation experience required; If without degree, please refer to requirements below:
MS degree 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
Associate degree 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
HS Diploma plus thirteen (13) years of relevant work experience, eight (8) years of project leadership experience, four (4) years of GMP experience, 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 biopharmaceutical manufacturing processes
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.
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, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Job - Biopharmaceuticals
Primary Location - Americas-US-CA-Fremont
Organization - US-BI Fremont
Schedule - Full-time