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Systems Validation Engineer at Boehringer Ingelheim

Systems Validation Engineer

Boehringer Ingelheim Ridgefield, CT Full-Time

Description:

Description\:

This position leads the facility, utility, and manufacturing equipment validation program for the facility engineering team including\: understanding user requirements and system specifications, conducting risk analysis,  protocol/test case development, test case execution, and summary report generation. This position creates understanding and supports the facility engineering team in the validation life cycle of systems including\: change control , incidents, deviation/CAPA, periodic reviews and retirements of systems. The position is critical to BI’s overall compliance effort and is responsible for ensuring that validation life cycle management conforms to current cGMP, GLP, FDA, EU, USDA and BI requirements.

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\:

  • Review and understand technical specifications and project plans to identify critical aspects of systems from the engineering perspective.
  • Develop risk assessments, validation protocols, test cases, execution strategies, and acceptance criteria based on established site, industry and regulatory standards\:
    • Work on multiple validation projects simultaneously and coordinate/perform test work;
    • Write IQ/OQ/PQ protocols for facilities, utilities and manufacturing equipment including  related automation or computer system;
    • Execute validation test cases according to protocol instructions and procedures;
    • Plan, coordinate and track the progress of validation projects;
    • Compile validation packages and assure all required documentation is complete.
  • Tracking and managing validation life cycle activities for multiple concurrent projects\:
  • Lead risk assessment exercises related to facility, utility, and equipment changes;
  • Support change control activities including review/approval of changes, preventive maintenance updates, calibration updates, drawing updates, SOP updates, and related investigations;
  • Perform periodic reviews of systems to understand the state of control over time.
  • Perform all Company business in accordance with regulations, Company policy and procedures.

Requirements\:

  • Bachelor's degree in Engineering or a Scientific discipline
  • 5-10 years of experience testing equipment and/or facility/utility commissioning
  • Programmable Logic Controller and process control system experience required
  • Understanding of technical aspects of utilities, mechanical systems and manufacturing equipment preferred
  • Understanding of Engineering Project Management and AutoCAD preferred
  • GxP experience preferred
  • Ability to plan, schedule, organize, prioritize, and coordinate project activities
  • Ability to function within cross-functional teams

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

  • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click [ Link removed ] - Click here to apply to Systems Validation Engineer for more information on the vaccine mandate and COVID-19.

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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Job ID: AR02-5950_2112239

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