
Manufacturing Technology Engineer
3 weeks ago
Overview
We are seeking a highly motivated Manufacturing Technology Engineer to join our client's dynamic and innovative biopharmaceutical facility in Cruiserath, Dublin 15.
This role offers the opportunity to play a key part in the technology transfer of new products within a state-of-the-art Multi Product Cell Culture facility.
It is a contract based 12 month opportunity.
The successful candidate will be a critical contributor to the Manufacturing Technology team, responsible for process validation, technical support, and continuous improvement initiatives for mammalian cell culture and primary recovery operations.
You will work cross-functionally with Manufacturing, Engineering, Quality Assurance, Quality Control, and Global Regulatory Sciences teams to ensure the successful introduction of new products.
Key Responsibilities
Lead tech transfer readiness activities, from facility assessment through PPQ execution and report completion for new product introductions.
Apply deep technical knowledge of upstream (cell culture) and/or downstream (purification) drug substance manufacturing processes.
Author technical documentation including protocols, reports, and SOPs supporting process validation.
Drive process improvements (e.g. yield optimization, cycle time reduction) using data analytics tools.
Lead and execute technical studies at commercial scale, providing on-the-floor support for troubleshooting and investigations.
Act as a subject matter expert during regulatory inspections and support external interactions with agencies.
Share technical learnings through internal/external presentations and contribute to Lean and continuous improvement initiatives.
Qualifications
Minimum BSc in a scientific or engineering discipline, with 3+ years' experience in drug substance manufacturing or technical support within the biopharma industry.
Proven track record in technology transfer, process validation, and GMP compliance.
Strong oral communication, technical writing, and interpersonal skills.
Ability to collaborate and influence across global, cross-functional teams.
Strong problem-solving skills with the ability to balance product quality and operational requirements.
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