Technical Transfer Engineer
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Job Ref | #1002160 |
| Job Views | 248 |
- Description
- We have an exciting new contract role on offer for our client, who is a leading biopharmaceutical company based in Dublin.You will be required to provide process development support to new product introductions (NPI) and lifecycle changes to site, contribute to subject matter expertise for unit operations and support ongoing production. Providing technical support to large molecule and small molecule drug product manufacturing on site as well as part of the global process development organisation your input will include support of process performance and implementation of process improvement strategies.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Contributing to new product introductions and lifecycle changes
Acting as a SME for these products following completion of the transfer to PM2 or PM3.
Contributing to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also contribute to responses to regulator questions as and when required.
Providing technical expertise 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.
Providing process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
Supporting commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
Interfacing with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
Helping in the development and characterisation of drug product processes and transfers technology to commercial drug product sites.
Identifying and implementing operational opportunities for current and new sterile operations.
Troubleshooting issues with drug product processing technologies and equipment.
Conducting risk assessment for drug product operations and proposes / implements appropriate CAPA.
Providing recommendations to management during investigations. Provide support to the and be a link to manufacturing on key investigations as a process expert.
Developing validation plans, process performance qualifications (PPQs) 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).
Participate in validation cross functional teams at the site to ensure adherence to required policies and procedures.
Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
Collate and report on relevant shipping and filter validation.
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 process.
Assist in deviation and exception resolution and root cause analysis.
Participate as required in project activities and be developing associated project skills.
What you need to apply:
Bachelor’s degree in Science or Engineering with 3-5 years’ experience in a similar role
PhD or Masters in Science or Engineering, would be preferred.
Knowledge of cGMPs and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills
Robust 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
Familiarity of Quality systems, Drug Product Manufacturing and Validation.
Experience working cross-functionally to advance complex projects to completion.
Outstanding communication skills