Job Description

Tech Transfer Engineer Engineer – Drug Product (NPI & Lifecycle Support)

Location: South Dublin
Reporting to: Process Development Senior Engineer

About the Role

Our client is seeking a dynamic Process Development Engineer to provide technical and operational support for new product introductions (NPI) and lifecycle management (LCM) changes at their manufacturing site. The role is key to overseeing process performance qualification (PPQ), serving as the product lead during product transfers, and supporting biologics drug product manufacturing. The successful candidate will work within the global Process Development organization and act as a subject matter expert throughout the product lifecycle.

Key Responsibilities

• Lead NPIs to manufacturing areas from a Process Development perspective and serve as SME post-transfer.
• Drive the success of product transfers from project initiation through characterization, engineering studies, PPQ, and regulatory approval.
• Troubleshoot and provide technical solutions for drug substance freezing/thawing, formulation, filling, lyophilisation, inspection, and transportation processes.
• Offer process development expertise in sterile processing, tech transfer, process characterization, and validation activities.
• Provide technical support for commercial drug product operations, including evaluation of Change Controls, NCs, and CAPAs.
• Develop and execute validation plans and PPQ protocols for vial and syringe filling processes.
• Ensure compliance with internal policies, GMP standards, and global regulatory requirements.
• Serve as the site’s key point of contact for global teams throughout the transfer and validation process.
• Participate in and support cross-functional validation and quality teams, assisting in investigations, risk assessments, and documentation updates.
• Support the evolution and maintenance of the site’s validation program, including guidance documentation and training initiatives.
• Report on relevant shipping and filter validation, and assist in deviation resolution and root cause analysis.
• Provide input to product quality assessments and process flow documentation.

Basic Qualifications

• Bachelor's degree in Science, Engineering, or 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes.
• Working knowledge of cGMP and international regulatory requirements.
• Strong analytical, problem-solving, and communication skills.

Preferred Qualifications

• Doctorate or Master’s in a science or engineering discipline.
• 5+ years supporting commercial protein drug product processing, particularly in sterile filling, freeze-thaw, mixing, and lyophilisation.
• Expertise in protein stability and characterization principles.
• Proven ability to manage multiple projects and allocate resources effectively.
• Strong knowledge of validation, quality systems, and regulatory compliance.
• Demonstrated leadership in cross-functional environments with excellent communication and stakeholder management skills.

Additional Information

• Shift Support: The successful candidate must be willing to provide 24/7 support (approximately once or twice per quarter, for 1–2 weeks at a time).
• Shift Rate: A 35% shift premium applies.
• Shift Pattern: 2 days on (7am–7pm), 2 nights on (7pm–7am), followed by 4 days off.