AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.
Job Description
We are currently looking for a Cleaning Validations Engineer to join us on our Ballytivnan site in Sligo. This person will execute cleaning validation tests in accordance with approved protocols, procedures, and guidelines within our biologics facility. As the Cleaning Validations Engineer, you will provide technical leadership in the area of cleaning validation and own the cleaning validation strategy for the site.
* Design, plan, and execute cleaning and process validation activities in accordance with regulations and guidelines.
* Create and implement the cleaning validation strategy.
* Analyze data and provide recommendations for improvements in cleaning/manufacturing processes.
* Provide technical leadership for deviation investigations related to cleaning validation activities (residual product/detergent and microbial contamination issues).
* Write technical cleaning evaluations as requested, including calculations and deviations with root cause and impact assessment.
* Generate closure and validation reports for cleaning validation of various equipment systems.
* Coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.
* Generate, maintain, and execute the Site Validation Master Plan.
* Generate, maintain, and execute Project Validation Plans and schedules.
* Generate validation protocols and final reports to cGMP standards.
* Create, review, and approve various quality documents and test data.
* Manage validation, exception event, and change control processes.
* Maintain and track validation equipment, if applicable.
* Complete all required training before executing a task.
* Document all activities in line with cGMP requirements.
* Perform cross-training within the team and training of new team members.
* Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
* Coordinate activities to maximize the effectiveness of all team members.
* Maintain overall cGMP compliance of the production areas.
* Communicate with peers and management regarding activities in the area, including elevation of events or concerns.
Qualifications
* Qualification and/or degree in engineering or scientific discipline.
* 3 years plus in cleaning validation.
* 3 years plus of knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry in a sterile environment.
* Strong communication (written and oral), presentation, and troubleshooting skills required.
* Ability to work well both independently and in a team environment.
* Capable of prioritizing work and multitasking.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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