Tech Transfer Lead

Great hybrid opportunity for a tech transfer engineer to play a leading role in an exciting Pharmaceutical project in Dublin. This is an hourly rate contract position with rates depending on experience. Responsibilities:

• Development of validation plans, process performance qualifications for vial and syringe filling.
• 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) with a full understanding of CMC business process related to technology transfer.
• Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
• Collate and report on relevant shipping and filter validation.
• Assist in deviation and exception resolution and root cause analysis.
• Contribute to product quality assessments and process flow documents.

• Third level Bachelor's degree in science, engineering
• 7+ years of experience.
• 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.