Systems Validation Engineer

Description: Boehringer Ingelheim, is currently seeking a talented and innovative Systems Validation Engineer in the Infrastructure, Safety, Environment & Engineering (ISEE) Department at our Ridgefield, CT facility.   This position performs turn-key facility and utility validation services for all internal customers including: risk analysis / determination, protocol development, protocol execution, and protocol summary reports. The position is critical to the validation life cycle will lead the change control process by understanding facilities and utilities and how changes may impact their qualified status. The position is critical to BI's overall compliance effort and is responsible for ensuring that validation practices conform 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:  Establish/Write validation protocols, 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 and utilities as well as related software. Execute validation work 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 change control activities for multiple concurrent projects.   Lead risk assessment exercises related to facility and utility changes. Support change control activities including review/approval of changes, preventive maintenance updates, calibration updates, drawing updates, SOP updates, and related investigations.  Review past validations in order to identify and champion process improvement projects and; ensure facilities and utilities remain in a qualified state. Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure. Responsible for implementing current trends in regulatory compliance for all facility and utility validation activities. Perform all Company business in accordance with all regulations and Company policy and procedures.   Requirements:   Bachelor's degree in Engineering or a Scientific Discipline 3- 5 years of hands on experience in facility and utility validation, pharmaceutical GxP preferred Process Logic Controller and process control system experience preferred Ability to plan, schedule, organize, prioritize, and coordinate project activities Ability to function within cross-functional teams Good knowledge of quality principles      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 1811780
Salary Range: NA
Minimum Qualification
Less than 5 years

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