Validation Engineer III - 10325

Organization
MedImmune
Job Location
Philadelphia, PA 19101
Job Description

Job Description:

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.

Supervision:

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.

Position Requirements:

Position:

Experience:

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

Education:

B.S. or advanced degree in a technical or engineering specialty required

Additional Notes:

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.

Apply online at: https://www.candidatecare.com/srccsh/RTI.home?r=5000073030510&c=921&d=me...

New study finds bias against female lecturers among student course evaluations, the Economist reports.

A research duo finds that science and technology graduate students who turn away from academic careers do so because of changes in their own interests.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.