Technical Transfer Engineer (Fill Finish)
Industry: Pharma/Biotech/Clinical Research
Work Experience: 4-5 years
City: Cork
State/Province: Cork
Country: Ireland
Job Summary: Job Description
PSC Biotech is a leading Biotech Consultancy firm with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in over 23 countries. We provide cloud-based software solutions for Quality Management and Regulatory Inspections.
PSC Biotech offers a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting. Our engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate.
Responsibilities:
1. Work with External Partners to deliver technical transfer of our vaccine and biologics programs.
2. Responsible for technical activities for the commercial manufacturing process at the External Partner, including authorship of change control and management of process improvement projects.
3. Responsible for technical transfer activities, authorship of GMP documentation, and regulatory filings.
4. Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
5. Ensure External Partners are inspection ready for routine inspections and/or inspections related to new product introductions or transfers.
6. Participate in creating, sharing, and adopting best practices and business process strategies.
Requirements:
1. Minimum 4 years post-bachelor's degree experience in a GMP functional area.
2. 3-5 years fill finish Technical Transfer experience.
3. Strong communication and teamwork skills.
Preferred Experience and Skills:
1. Experience in Fill Finish activities.
2. Demonstrated ability to independently manage projects/work to schedule/deadlines.
3. Statistics experience.