Technical Transfer Specialist
4 days ago
This role plays a key part in the development of drug products in our facility.
The purpose of this Technical Engineering role is to lead activities delivering on Tech Transfer requirements needed to support New Product Introduction. This includes:
- Tech Transfer
- Validation programs & strategies
- Technical support and process improvement projects
- Network support & collaboration
To ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and cGMP principles in day-to-day activities and all applicable job functions. Compliance requires documentation completion, risk assessments, closing out corrective action, participating in audits and inspections and proactively highlighting any issues around compliance.
Responsibilities:
- Lead and execute process engineering and validation activities to support technical transfers
- Manage multiple Technical Engineering projects needed to support the business
- Collaborate closely with cross-functional teams to establish scope in improvement projects up to a fully commercial site
- Deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team
Requirements:
- A bachelor's Degree or higher in Science, Engineering or other Technical discipline
- Minimum 4 years experience ideally in manufacturing, preferably GMP setting
- Green Belt preferable Process engineering and/or validation experience in a sterile manufacturing environment
- Proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects
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