The Validation Engineer executes the validation plans and processes for facilities, laboratory equipment, utility systems and process equipment. The validation engineer authors validation protocols and reports that reflect the validations performed.
Major Duties include:
* Author and execute validation protocols
* Participate in equipment design, evaluation, and procurement
* Perform equipment start-up, shakedown, and cycle development
* Participate in SOP development as needed
* Coordinate effectively with other departments regarding validation project plans.
Works under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain.
Familiarity with FDA regulated biotechnology or drug validation requirements and 3+ year's experience in validation.
Validation II engineer: MS >2 years, BS >3 years
Validation III engineer: MS >3 years, BS >5 years
B.S. or advanced degree in a technical or engineering specialty required
Must have in depth experience in at least five of the following areas: Experience in process validation of biological process; method validations; filter validation; sterility validation -- autoclaves, SIP of piping and tanks; FAT experience with automated process equipment; setting validation specifications for purchasing capital equipment or instruments; project management experience with facilities upgrades and major construction projects; experience performing IQ/OQ on automated process equipment; cleaning validation; shipping validation.
Able to read P&ID, Isometric and "As Built" drawings desirable.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.