Tech Transfer Engineer

4 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview

Tech Transfer Engineer – Ireland, Dublin – 12 Month Contract. One of the top 10 best companies to work in Ireland is looking for a Tech Transfer Engineer for their large-scale new facility in Dublin. An exciting project with opportunity to learn new technology and develop current skills within a fast-paced €1 billion project. The client offers the opportunity to work within a large-scale environment with cutting edge technology.

What you’ll do

- Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the MPCC Cruiserath.
- Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of cGMP and regulatory principles.
- Generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
- Provide on-the-floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolution.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.

What you’ll need

- Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
- Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.

If this role is of interest, please apply now

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