Job Title: Process Validation Engineer
Overview
Location: Dublin, Ireland
Contract Duration: 12 months initially
We are seeking a skilled Process Validation Engineer to support our team in driving innovation and improving processes.
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Key Responsibilities
1. Support the development and implementation of scientifically sound validation and technical transfer guidance based on current regulations, industry standards, and best practices.
2. Promote innovative and efficient approaches to validation and technical transfer incorporating science and risk-based methods.
3. Collaborate with the ATO team to continuously improve validation and technical transfer practices across the network using a lean and standardized approach.
4. Develop and maintain validation and technical transfer process tools, including templates, tracking systems, knowledge management tools, and digital solutions.
5. Work closely with other team members to implement business improvements.
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Requirements
* A minimum of 7 years' progressive experience in the biopharmaceutical or pharmaceutical industry (product development, MSAT, technical services, or quality).
* Experience in biopharmaceutical bulk drug substance manufacturing and aseptic fill finish.
* In-depth knowledge of regulations, industry practices, and experience interpreting and applying guidelines and regulations.
* Strong track record of working in a global and matrix environment, collaborating cross-functionally.
* Experience in developing and using Smart Sheet as a tracking solution is an advantage.
* Experience with Kneat Digital validation solutions is an advantage.
If you are interested in this opportunity, please apply now.