34499-Process Engineer-Tech Transfer – Dublin Contractor

Process Development Engineer – Tech Transfer

Purpose

This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing.

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 organizational 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.

Qualifications

•Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role
• Knowledge of cGMPs and other worldwide regulatory requirements.
• 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.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approx. 1-2 weeks at a time. 35% shift rate applies.
Confirmed shift pattern: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off