Validation Engineers
Multiple openings for Qualification/Validation Field Specialists with a focus on temperature mapping and/or cleaning validation.
This is a long term contract assignment in the Lansdale, PA area. Local candidates ONLY! Candidates must also have unrestricted rights to work in the US.
Description:
Under general supervision, the individual performs standard studies for less complex work. Incumbent is expected to assist in conducting tasks such as generating and formatting cGMP documentation, insuring regulatory compliance in a specific area or collecting and reviewing field documentation.
Other Job Responsibilities:
Work performed will be in the following areas:
o VAQTA and VVSS
o PQ (temperature mapping) for Control Temperature Unites (CTU) (Freezers, Refrigerators, incubators, warehouse);
o PQ (temperature mapping) for Autoclave, Dry Heat Oven, waste inactivation; and
o PQ (cleaning validation) for Chromatography skids and columns and washers.
Basic Qualifications:
The ideal candidate will possess the following requirements:
Minimum 2 years experience in CandQ field including:
o Relevant Performance Qualification experience in one of more of the following equipment: freezers, refrigerators, incubators, autoclaves, dry heat ovens, washers, filters, chromatography skids, chromatography columns;
o PQ experience mainly in temperature mapping and cleaning validation;
o Documentation development / management and discrepancy / exception management knowledge;
o Relevant temperature mapping field testing experience;
o Relevant cleaning validation, clean and sanitization hold time validation studies and cycle development studies;
o Laboratory testing and sampling coordination experience; and
o Excellent documentation skills, including handling of large size protocols (writing protocol/summary report, filing studies, scanning completed validation packages.)
Other Preferred/Minimum requirements:
BS/BA and 2 years experience in C and Q field or equivalent combination of education and experience;
Strong safety background;
Team oriented;
GMP background; and
Support technical reports for Gamma irradiated, tube sealers and welders, filters validation.