Drug Product Process Specialist

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

We are seeking a Drug Product Process Specialist to provide technical and programme support across relevant functional departments and new product introductions (NPIs) at the Manorhamilton Road site.

This role will play a key part in supporting manufacturing operations, process optimisation, troubleshooting, and continuous improvement activities. The successful candidate will contribute to the delivery of projects that improve product quality, yield, throughput, and cost efficiency while supporting compliant and robust site operations.

Key Responsibilities

• Provide technical support for manufacturing and process-related issues, including daily troubleshooting, process optimisation, cost reduction, and coaching of manufacturing personnel.
• Support commissioning and validation activities during project start-up.
• Support process and equipment optimisation to sustain and improve product quality, yield, and throughput.
• Execute process development activities on existing products and late-stage clinical products, including scale-up to plant equipment.
• Identify and support continuous improvement opportunities, working cross-functionally to implement agreed improvements.
• Provide on-the-floor technical support to the production team for process and equipment optimisation and troubleshooting.
• Manage and contribute to continuous improvement projects.
• Develop and update batch and cleaning documentation for NPIs.
• Support process front runs for both NPI and commercial processes.
• Develop process control recipes for NPIs and optimise existing commercial process recipes.
• Adhere to and support all EHS&E standards, procedures, and policies.

Qualifications and Experience

• Relevant third-level degree or higher qualification in chemical engineering, process engineering, or a related technical discipline.
• Minimum of 2 years’ experience in process engineering.
• Experience in batch processing, automation, technical transfers, scale-up, commissioning, and validation within a cGMP pharmaceutical environment.
• Experience supporting new product introductions or technology transfers into pharmaceutical facilities is desirable.
• Demonstrated project management skills, with the ability to deliver projects on schedule and to defined quality standards.

Skills and Competencies

• Strong problem-solving skills and the ability to work effectively under pressure.
• Strong analytical and innovative thinking.
• High attention to detail and a strong compliance mindset.
• Results-driven with a commitment to quality.
• Excellent verbal and written communication skills.
• Strong interpersonal and teamwork skills.
• Understanding of and commitment to Perfect Performance principles.

Accountability and Impact

• Support successful commercial product campaigns.
• Contribute to the successful introduction of NPIs on site.
• Demonstrate persistence and ownership to ensure issues are fully resolved.
• Partner with the EHS&E team and take technical leadership on process safety topics where required.
• Demonstrate a Right First Time mindset in all activities.

Leadership and Influence

• May be required to lead cost improvement projects.
• Build and maintain strong working relationships with PDS&T and GPRD.
• Provide technical leadership to functional areas and collaborate with key stakeholders.
• May lead sub-projects related to commercial or NPI activities.
• May provide cross-training and guidance to new team members and support the development of training materials.

Decision-Making

• Work in accordance with all procedures, policies, and guidelines to ensure compliance with cGMP, HPRA/FDA regulations, and company requirements.
• Support continuous improvement through Lean tools and principles.
• Apply functional expertise to support daily operations.
• Seek manager input on decisions that may have a significant impact on the area.

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

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