What are the responsibilities and job description for the Senior Validation Engineer position at Meet Life Sciences?
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
Salary : $110,000 - $125,000