- Posted 06 March 2025
- LocationIreland
- Job type Fixed Term
- Reference1810
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Author technical documents including validation protocols, reports, and SOPs.
Identify and implement process improvements to enhance yield, cycle time, and efficiency using data analytics tools.
Execute and oversee plant support studies and commercial-scale technical studies on the manufacturing floor.
Provide on-the-floor troubleshooting support, leading investigations into process deviations and resolutions.
Support regulatory inspections and act as a technical SME for regulatory interactions.
Document and communicate process learnings across internal and external scientific forums.
Drive process improvements through change control, CAPA, and Lean initiatives.
Tech Transfer Engineer, Manufacturing Technology
Job description
A global leading biopharmaceutical manufacturer is seeking a Technology Transfer Engineer to support the tech transfer, validation, and technical operations for a new product introduction. This role will be key in ensuring successful process validation, troubleshooting, and continuous improvement within a commercial-scale Multi-Product Cell Culture facility.
Key Responsibilities:
- Lead technology transfer activities from facility assessment through PPQ execution and report completion for a new product introduction.
- Act as an SME in Downstream Processing (DSP), including:
- Buffer preparation, purification, chromatography, viral reduction filtration, ultrafiltration, viral inactivation, DS formulation, and bulk fill.
Qualifications & Experience:
- BSc or higher in a scientific or engineering discipline with 3+ years of experience in drug substance manufacturing technical support.
- Experience in tech transfer preparation, execution, and post-execution activities.
- Strong understanding of cGMP compliance and regulatory requirements.
- Excellent technical writing and verbal communication skills.
- Strong ability to collaborate across cross-functional global teams.
- Ability to influence stakeholders and drive technical decisions balancing product quality and operational efficiency.
Additional Information:
- The role may require extended hours, modified work schedules, or on-call availability.
- This is an on-site position, requiring physical presence to support collaboration, innovation, and productivity.
What’s on Offer?
- Exciting contract opportunity within a leading biopharma manufacturing facility.
- Work in a highly technical and collaborative global environment.
- Opportunity to lead tech transfer projects and drive process innovation.
Interested? Apply today to discuss how this role could be your next career move!