Process Specialist

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.

Job Description

AbbVie Ballytivnan is a Centre of Excellence for Precision High Volume Moulding and Auto-Assembly, and is a state-of-the-art Biologics aseptic fill finish facility.

We are looking for a Single Use Process Specialist to join our Technical Operations Team in Ballytivnan, Sligo. You will work closely with site cross-functional teams and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes. This position reports to the NPI Technical Manager. This is an exciting time to join our Technical Operations team as we grow and bring new products and technologies to the site. To be successful in this role you need to be initiative-taking, have strong collaboration skills and be able to work to strict project timelines.

Roles and Responsibilities

- Work closely with site cross‑functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes.

- Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.

- Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.

- Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records.

- Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path.

- Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations.

- Monitor and analyse process data during the manufacturing.

- Support, supervise, and train operations personnel for SU processes.

- Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned.

Qualifications

- Degree in science, engineering, or other relevant technical subject area

- 2+ years direct experience in the use of single use materials for biologics manufacturing in GMP environment e.g., in operations, technical operations, and process validation.

- 1+ years experience in the design, onboarding, and qualification of single use assemblies for biologics manufacturing

- Experience in client‑facing role collaborating with vendors and global stakeholders to advance.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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

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