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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Validation Engineer

Branchburg Township, New Jersey Req ID 2122506 Category Quality Assurance Division AbbVie

Summary: Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results; prepares final reports that identify the results of protocol testing and the conditions of release.

Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

 • Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

• Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.

• Assures that protocols are approved through proper channels; writes and revises validation protocols.

• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.

 • Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization. • Assures that all test data is gathered and recorded in accordance with cGMP requirements.

• Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.

• Writes final reports and assures that they are approved through proper channels.

• Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.

• Develops and communicates project timelines and status.

• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.

• Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring Knowledge of: • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. • Pharmaceutical principles, practices and applications. • English usage, spelling, grammar and punctuation. • Personal computer operations and Microsoft applications (Word, Access, and Excel).

• Communicating clearly and concisely, both orally and in writing.

Qualifications:

Bachelor’s degree in Engineering or a related field from an accredited college or university and two (2) to (4) four year of validation experience, preferably in a pharmaceutical environment, or an equivalent combination of training and experience.

 

Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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