This position has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new equipment, facilities, and/or utilities.
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:
- Facilitate changes to existing production processes.
- Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment.
- Assist validation of new equipment and changes to existing equipment including document generation.
- Act as change control owner for equipment and process improvement projects.
- Coordinate change control meetings.
- Assign action items for change control.
- Accountable for closing out change control action items and documentation.
- Documentation includes P&ID drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required.
- Support manufacturing in troubleshooting product and equipment issues.
- Respond to requests for support from production.
- Identify improvements to manufacturing process.
- Improvements may include mechanical, automation, or workflow.
- Work with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project.
- Responsible for User Requirement Specification development.
- Assist Principle Process Engineers in the execution of small scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects).
- On larger capital projects, the engineer will work with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design.
- The engineer will develop specifications (user, functional, and detailed design) for equipment and automation of the equipment.
- Develop and maintain overall knowledge of facility processes and products.
- Provide training on process and/or equipment modifications as required for new or existing equipment/processes.
- Act as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance.
- Bachelor of Science Degree in Engineering or related science from an accredited institution.
- Three (3) years’ applicable experience, engineering or scientific in nature in a GMP environment –OR- Five (5) years’ engineering or scientific experience outside of a GMP environment.
- At least one (1) year of experience leading projects required.
- Communicate verbally and in writing effectively with all levels of corporate and local management and employees.
- Ability to plan, schedule, organize, prioritize, and coordinate project activities.
- Ability to understand and work within a regulated environment.
- Experience with GAMP Automation practices and documents preferred.
- Ability to function in a leadership role as well as in a team environment.
- Ability to manage multiple projects at one time.
- Analytical Thinking
- Customer Focus
- Decision Making
- Planning and Organizing
- Conceptual / Analytical Thinking Scope
- Delivering Results
- 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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. 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.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.