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 & Experience
- 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.
