Validation Engineers with 21 cfr part 11, usp 1058, GMP, GxP, regulatory, calibration and test, data analysis.
20th July, 2020
Need 4 Validation Engineers - GMP
3-5 yrs experience with computer systems validation, will be doing document writing, csv deliverable creation, working with project teams to lead a deliverable creation and execution, laboratory systems experience is helpful, life sciences or other regulated industries are preferred (any stem based industries that utilize lab environment). We will consider candidates who can relocate (will need to be accessible to office on as needed basis for lab purposes during outbreak). BA Degree or equivalent experience is acceptable.
Technical skills – gmp (good manufacturing practices), 21 cfr part 11, usp 1058 – these are relevant industry regulations and guidance’s so experience or exposure to these validations is what we are focusing for this role (highly preferred). Candidates who have designed/altered/executed computerized validation systems and the gamp5 model is preferred
Summary Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors. This role is intended for use by companies in the Life Sciences and Medical Device industries and should be used for those individuals validating results for clinical research, clinical trials and manufacturing testing.
Job Description The CSV will document and validate the deployment of Windows 10 upgrades and document changes respectively. Candidate will write, edit, route and approve appropriate documentation associated with each system upgrade and good documentation skills are a must. Candidate will need to be able to execute test protocols as needed for each upgrade. Candidate will need to be able to work on multiple projects at the same time and manage priorities. Working independently is a must. The Analyst will provide project management updates to both customer and management, and must be willing to travel to customer site.