Principal Specialist, Computer & Equipment Validation- Contract
North Brunswick, NJ

Job Description

Description:

The Principal Specialist, Computer and Equipment Validation leads computer and equipment validation activities, primarily for BI Animal Health R&D (BIAH R&D) Pharmaceutical Sciences at Ingelheim Germany (LGC), Duluth GA USA (DUL), and North Brunswick NJ USA (NOB) and also supporting other BIAH R&D sites. Leads a cross functional team to ensure validation compliance at multiple BIAH R&D sites. Establishes procedures, reviews systems for compliance, and represents BIAH R&D in global teams and committees regarding validation.

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 and maintain functional and local procedures and guidance for computer and equipment validation. Provide training for BIAH R&D validation participants.
* Lead validation activities throughout computerized systems validation lifecycle (implementation, production use, changes, retirement). Author and review/approve validation documentation.
* Ensure inspection readiness and conduct reviews of computer systems and equipment.
* Lead a cross-functional team of validation managers supporting other BIAH R&D functions.
* Support audits and inspections.
* Represent BIAH R&D in global BI teams and committees regarding validation.

Requirements

* Ph.D. or M.S. from an accredited institution plus four (4) years of work experience, or B.S. from an accredited institution plus six (6) years of work experience in Chemistry, Computer Science, or related field.
* Excellent skills in interpersonal communication, organization, time management, technical writing, attention to detail, and ability to follow complex procedures precisely
* Strong leadership and conflict resolution skills.
* Customer focus, integrity, and teamwork.
* Computer systems and validation experience.
* Achievement focused with appropriate alignment for regulatory and quality requirements.
* Transparent in communication of failures.
* Positive attitude and willingness to take smart risks.

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

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, 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.

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