Validation Engineer I/ II

Duties:

Work Location or Remote On-site

Remote? No

Full time or part time? Full time

Shift Hours 40/week

Number of Positions 1

Any possibility of the assignment to be converted to a full-time role? Not at this time

Duties

Perform Smoke studies and assist in semi annual Media fill qualifications as a SME

Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.

Has worked with Ellabs data loggers and software

Write and execute protocols and complete final reports.

Understanding of cleaning validation concepts and principles.

Understands pharma grade utilities ( water HVAC, gases)

Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.

Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.

Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready" at all times.

Support Change Control, Deviation and CAPA activities

Skills:

Skills

Aseptic processing

Protocol generation

Sterilization

Validation

FDA/USDA

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.