Easter Seals Jobs

Company Description

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 (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

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 the implementation of 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 the closure and validation report for cleaning validation of various equipment systems

• To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.

• Generation/maintenance/execution of the Site Validation Master Plan.

• Generation/maintenance/execution of Project Validation Plans and schedules.

• Generation of validation protocols and final reports to cGMP standards.

• Creation/Review/Approval of various quality documents and test data.

• Management of validation, exception event, and change control processes.

• Maintenance and tracking of validation equipment, if applicable.

• Completing all required training before executing a task.

• Documenting all activities in line with cGMP requirements.

• Performing cross training within the team and training of new team members.

• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.

• Coordinating activities to maximize the effectiveness of all of the team members.

• Maintaining the overall cGMP compliance of the production areas.

• Communicating 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 only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html