Process Scientist

Job Overview

PE Global is seeking an NPI Process Scientist for a 12-month contract position based at our client facility in Sligo, Ireland. This role supports Technical Operations, reporting directly to the NPI Technical Manager.

Key Responsibilities

• Developing manufacturing processes for new products.
• Providing technical support to resolve process operation issues.
• Conducting gap analyses, facility suitability studies, process safety, and risk evaluations for new product introductions.
• Monitoring and analyzing process manufacturing data.
• Preparing and updating specifications for NPI materials and consumables.
• Leading or supporting risk assessments such as PFMEA and Environmental Health and Safety (EHS).
• Creating NPI documentation including transfer plans, protocols, procedures, and batch manufacturing records.
• Collaborating with global science and quality teams on process development for future AbbVie products.
• Managing product and process investigations and change initiatives.
• Supervising, supporting, and training operations staff on NPI processes.
• Complying with and promoting all EHS&E standards and policies.

Qualifications and Experience

• Degree in engineering, science, or a related technical discipline is required; a Master's degree is preferred.
• At least 3 years' experience in pharmaceutical process engineering involving batch processing, technical transfers, and scale-up within cGMP pharmaceutical or biologics settings.
• Experience with new product introduction in biologic manufacturing environments is advantageous.
• Minimum 1 year in a similar role and 1 year in pharmaceutical or biologic industries.
• In-depth technical and operational knowledge of unit operations in fill-finish facilities.
• Exceptional attention to detail and focus to ensure compliance and accuracy.
• Results-oriented, aiming to meet established site and departmental targets and metrics.
• Leadership experience overseeing sub-projects related to commercial or NPI activities.
• Ability to motivate, select, and train capable team members to achieve departmental goals.
• Effective communication skills to guide assigned staff and contribute to talent management.
• Ability to work mainly autonomously with supervision from the NPI Technical Manager.
• May provide intermittent supervision for Operations Development Personnel or interns.
• Knowledge of medical surveillance programs is also pertinent.

Additional Information

This role involves working on-site in Sligo and adheres to a 12-month initial contract. The candidate will be expected to align with departmental objectives which are reviewed regularly. Interested applicants should submit their CV promptly to the designated contact for consideration.