Validation Engineer II Job in Bedford 44146, Ohio Us
Our Culture
At Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do.
Validation Engineer II
Boehringer Ingelheim is currently seeking a talented and innovative Validation Engineer II to join our Validation department located at our Bedford, OH facility.
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:
- Under the guidance of the area supervisor and senior engineers, execute IQ, OQ, PQ, and Requalification studies per approved protocols/ procedures. This includes independently drafting routine test protocols, analyzing test data and preparing technical reports. This individual must be able to make decisions on acceptance of test results and coordinate repeat testing and corrective action if needed with guidance of supervision, arrange test schedules/ material supply with BVL and outside labs associated with study execution and effectively communicate facility/ equipment needs to production/ scheduling to facilitate study execution.
- Prepare test equipment and components used in the execution of validation activities such as preparation of thermocouple wires, Kaye validators, vials with sodium chloride coating, depyrogention of glassware, etc.
- Under the guidance of supervision, draft standard operating procedures and revise existing operating procedures to ensure compliance with current regulatory requirements and validation outcomes.
- Participate in meetings relating to study design/ execution, making and communicating decisions effectively.
Qualifications
Required Education Experience:
- Familiar with cGMP requirements and industry standard validation practices. Good written and verbal communication skills.
- Computer skills -- Microsoft Office, including Word, Excel, PowerPoint, Access and Outlook
- Experience with Microsoft Project
- Other relevant software programs required for the position (i.e. Trackwise, MfgPro, AMMS, etc.)
- Communication skills -- both oral and written (good, excellent or strong)
- Ability to communicate across the organization
- Ability to comprehend and follow procedures in a cGMP environment
- Project Management skills experience
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Desired Experience, Skills and Abilities:
- Ability to work with multiple groups and people effectively
- Ability to analyze complex technical issues and data
- Effective communication (verbal writing) skills
- Document errors
- Ability to work in a fast-paced environment and meet timeline commitments with quality work
- Ability to work independently and make decisions with minimal oversite from validation management
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 background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V
