Job Description
Technical Transfer Engineer (Fill Finish) for leading Biotech Consultancy firm PSC Biotech in Cork, Ireland.
PSC Biotech is a global company with operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in 23 countries.
As a Technical Transfer Engineer, you will ensure internal and external manufacturing operations remain operational, continuously improve, and innovate.
Responsibilities include:
• Work with External Partners to deliver technical transfer of vaccine and biologics programs.
• Manage commercial manufacturing process at External Partner, including authorship of change control and statistical analysis of process performance.
• Author GMP documentation and regulatory filings.
• Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
• Develop standardized work to meet GMP requirements.
• Ensure External Partners are inspection-ready for routine inspections and/or inspections related to new product introductions or transfers.
• Participate in creating, sharing, and adopting best practices and business process strategies.
Required Education, Experience and Skills:
• Minimum 4 years post-bachelor's degree experience in GMP functional area or support of a GMP functional area.
• 3-5 years fill finish Technical Transfer experience.
• Strong communication and teamwork skills.
Preferred Experience and Skills:
• Experience in Fill Finish activities (Vial/Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.).
• Statistics experience (including Proactive Process Analysis and Continuous Process Verification).
• Experience in deviation management and/or change control and/or equipment support, and/or project management.