Job Details

Senior Validation Engineer

Full-time, permanent hire

Orange County-based - 5 days onsite

We're open to relocators

They cannot provide sponsorship at this time

We're partnered with a leading contract manufacturing organization providing aseptic manufacturing, development and analytical services for parenteral drugs. They are seeking a Senior Validation Engineer to lead on DQ, IQ, OQ, and PQ activities for manufacturing of sterile injectable and biopharmaceuticals. This is a hands-on position requiring an independent validation engineering leader.

Responsibilities:

• Lead and execute validation activities for aseptic filling lines, autoclaves, lyophilizers, sterile filtration systems, cleanrooms and more
• Author, review, and approve validation protocols, interpret and review data, and write final reports
• Develop and maintain validation master plans
• Lead validation for utilities such as WFI, clean steam, HVAC systems, and compressed gases.
• Be the SME for validation and sterile manufacturing
• Lead change controls, CAPAs, deviations, and risk assessments

Requirements:

• 5+ years of hands-on experience in validation engineering of sterile injectable pharmaceutical manufacturing
• Ideal experience in drug product fill finish for peptides and small molecules - for prefilled syringe-delivery
• Strong experience working with autoclaves, sterile filtration, aseptic fill-finish, lyophilizers
• Hands on! Need to be onsite and lead validation

Contact:

If you're interested, apply to this job and reach out to Amit at amit.uma@meetlifesciences.com