Process Engineer

PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Dun Laoghaire.

This is an initial 12-month contract position with a 24/7 shift is not mandatory but may be required once or twice a year for one to two weeks at a time, shift rate applies.

ROLE:

• The Process Engineer will lead new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
• The Process Engineer will be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
• Process Engineer will provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
• Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
• Identifies and implements operational opportunities for current and new sterile operations.
• Troubleshoots issues with drug product processing technologies and equipment.
• Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development and execution of validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross functional team.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Contribute to product quality assessments and process flow documents.
• Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated product.
• Lead or assist in deviation and exception resolution and root cause analysis.
• Participate as required in project activities and be developing own project management techniques.

REQUIREMENTS:

• A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***