Technical Services Engineer

A Technical Services Engineer is required by CareerWise Recruitment for our County Galway based client. As Technical Services Engineer, you will support the delivery of 3-year commercialization program for a new cartridge-filling product line and will be primarily responsible for activities related to product and process performance and for the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes, while ensuring compliance with cGMP and global regulatory expectations while driving process robustness, efficiency, and continuous improvement. #3-YEAR-Contract role__THE ROLE:

• Lead process validation (PPQ) and ongoing process verification activities for sterile drug products
• Ensure product and process-related technical services align with regulatory and internal standards
• Lead design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency
• Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes
• Initiate and lead process risk assessments (FMEA, Ishikawa, etc.) and implement risk mitigation strategies
• Analyze process and performance data to identify trends, reduce variability, and improve yield
• Support investigations, root cause analyses, and CAPA implementation for process deviations or non-conformances
• Lead the technical aspects of scale-up, technology transfer, and commercialization of new products
• Collaborate with R&D, Manufacturing, Quality, Engineering and Regulatory Affairs to ensure smooth transitions from development to commercial production
• Provide SME-level input into process validation protocols, batch records, and regulatory documentation
• Identify qualification and validation requirements for new product introductions.
• Stay current with evolving regulatory expectations (Annex 1, FDA, EMA, ICH Q8–Q10) and integrate best practices into process management.
• Ensure completion of PPQs, transfers, and process improvement projects within agreed timelines
• Maintain zero critical/major audit findings related to process validation or robustness
• Demonstrate measurable gains in process consistency, quality, and productivity.
• Perform other duties as assigned

REQUIREMENTS:

• Bachelor’s or Master’s Degree in Pharmaceutical Science, Chemical/Biochemical Engineering, or related field
• 5–8 years’ experience in Pharmaceutical Process Development, Technical Services, or Manufacturing, ideally in Sterile Injectables
• Project Management Certified (would be an advantage)
• Strong knowledge of Aseptic Processing, Process Validation (PPQ), and scale-up
• Experience with DOE, SPC, and process modeling tools (e.g., Minitab)
• Deep understanding of CPPs, CQAs, and Control Strategy Design
• Knowledge of Microbiological principles and Sterility Assurance
• Excellent analytical, problem-solving, and leadership skills
• Proven ability to lead cross-functional teams and deliver complex technical projects