The Validation Engineer II will be responsible for qualifying equipment used in manufacturing and packaging processes, along with supporting utilities in a regulated environment. This includes systems related to cleanroom HVAC, purified water, water-for-injection, compressed air, and nitrogen, ensuring compliance with industry standards for various stages of pharmaceutical product development and production.
Primary Responsibilities:
- Conduct validation activities for manufacturing and packaging equipment, as well as utility systems like cleanroom HVAC, water systems, and compressed gases.
- Collect and analyze laboratory data, identifying and correcting any discrepancies before reporting.
- Draft, review, and approve protocols and procedures for validation processes.
- Mentor less experienced team members and oversee work done by contracted validation personnel.
- Manage temperature mapping studies for storage areas and temperature-controlled units at the facility.
- Compile reports, maintain documentation, and ensure proper routing for approvals.
- Review operating procedures for equipment used in production and packaging.
- Perform risk assessments to outline qualification approaches and rationale.
- Determine appropriate sample sizes for equipment validation activities.
- Support tasks related to change control processes.
Qualifications:
- A degree in Engineering, Life Sciences, or a related field
- Relevant experience in validation work within a regulated environment, or a comparable combination of education and experience.
- Strong understanding of regulatory guidelines and industry best practices.
