Validation Specialist
Description:
Role: Validation Specialist
Location: Rensselaer, NY - Onsite
Duration: 6+ Months
**Only W2**
Our client is seeking two skilled Validation Line Support Consultants to support the launch of a new isolator-based fill-finish production line. These roles focus on validation lifecycle documentation, protocol execution, and hands-on development of VHP and temperature mapping cycles.
Key Responsibilities:
Develop and validate VHP decontamination and temperature mapping cycles.
Draft, review, and support lifecycle validation documentation.
Collaborate with engineering teams on commissioning and qualification protocols.
Execute validation protocols on the production floor.
Apply knowledge of Biological Indicator (BI) processes.
Requirements:
5+ years in validation within pharmaceutical or biotech environments.
Hands-on experience with isolator systems and fill-finish processes.
Expertise in VHP cycle development and temperature mapping.
Strong understanding of BI and lifecycle validation practices.
ValGenesis experience a plus (not required).