Tech Transfer Engineer

3 weeks ago

Dublin Pike, 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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