Systems Validation Engineer

4 weeks ago

Ridgefield, United States Boehringer Ingelheim Pharmaceuticals Full time
Description

Develop and implement validation protocols for the validation of mechanical / electrical equipment, control systems, and manufacturing equipment in order to conform with current validation industry standards and BI policies and procedures. 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.

Compensation: This position offers a base salary typically between $105,000 and $145,000 USD. There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

Duties & Responsibilities

  • Perform turn-key equipment / utility validation services for all internal and external GxP customers including risk analysis / determination, protocol development, protocol execution, protocol summary reports.
  • Perform technical review of changes to critical systems prior to implementation. Support / perform ad hoc testing for implementation and documentation for both internal and external customer change control requests for all validated equipment.
  • Support/ perform reviews of past validations as required to support the validation life cycle.
  • Collaborate with Engineering and Technology, Project Management/Facility Engineering, and external customers to facilitate the Critical Equipment Validation Life Cycle.
  • Assist with internal and external audits.
Requirements
  • Bachelor Degree from an accredited institution in Engineering, Scientific discipline or equivalent experience.
  • Five to ten (5-10) years experience of hands on experience in validation.
  • Programmable Logic Controller and Process Control Systems Experience.
  • Experience with FDA and GxP requirements.
  • Strong skills in GxP documentation and regulations as well as Validation.
  • Strong customer focus and prioritization skills.
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.
  • Excellent attention to detail.

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