Tech Transfer Engineering Lead – Biopharma Industry
11 month contract
Carlow - Hybrid Role
AMC22885

Are you an experienced and dynamic engineering professional looking for an exciting opportunity in the biopharma industry? This is your chance to play a pivotal role in the development of a cutting-edge manufacturing facility that supports the introduction of new drug products.

Position Overview: We are seeking a Technical Engineering Lead for an award winning biopharmaceutical company in Carlow.

In this role, you will be responsible for leading activities to support New Product Introduction and ensure the seamless technical transfer of processes. You will collaborate across multiple teams to deliver key engineering solutions, ensuring compliance with quality standards, regulations, and safety protocols.

Key Responsibilities:

• Process Engineering & Validation: Lead process engineering and validation activities to support technical transfer and ensure efficient, compliant operations.
• Project Management: Lead and manage various technical engineering projects, including process improvements, capital projects, and lean initiatives. Collaborate with cross-functional teams to establish scopes and deliver projects on time and within budget.
• Continuous Improvement: Promote lean six sigma methodologies and data-driven decision-making to drive operational excellence and process efficiencies.
• Technical Expertise: Act as a subject matter expert in equipment design, process design, and validation. Collaborate with global teams and specialist vendors to deliver projects effectively.
• Safety & Compliance: Collaborate to drive a safe and compliant work culture, ensuring adherence to relevant regulations and good manufacturing practices (cGMP). Work with multiple teams to support technical transfer programs and ensure continuous improvement.

• Experience: Significant experience in process engineering or validation within a highly regulated environment, preferably in a sterile manufacturing setting such as aseptic filling. Proven track record of successfully leading engineering teams through technical transfers and change management initiatives.
• Technical Knowledge: Strong understanding of regulatory requirements, sterile filling processes, equipment design, and validation in a sterile environment. Experience with automation, MES, and QbD/CPV is desirable.
• Methodologies: Expertise in Six Sigma, Lean methodologies, and data analysis. Familiarity with statistical process control and structured root cause analysis is a plus.
• People Skills: Excellent leadership, communication, and interpersonal skills. Ability to work effectively in cross-functional teams and manage multiple priorities simultaneously.
• Education: A degree in Science, Engineering, or a related technical field. Green Belt certification is preferable.