Job Description
A Process Validation Engineer is sought to support the company's mission to drive innovation in the pharmaceutical industry.
Key Responsibilities:
* Develop and implement scientifically sound validation strategies aligned with current regulations, industry standards, and practices.
* Drive innovative approaches to validation incorporating science and a risk-based approach.
* Support the ATO team to continuously improve validation practices across the network using a lean and standardized approach.
* Develop validation process tools, including templates, tracking tools, and knowledge management systems.
* Collaborate with the ATO validation team on business improvement initiatives.
Requirements:
* Minimum 7 years' experience in the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services, or Quality).
* Experience in biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
* Extensive knowledge of regulations, industry practices, and guidelines interpretation.
* Strong track record of working in a global matrix environment, with cross-functional collaboration.
* Experience with Smart Sheet as a tracking solution is advantageous.
* Experience with Kneat Digital validation solutions is advantageous.