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POST DATE 8/11/2016
END DATE 12/19/2016
JOB DESCRIPTIONVALIDATION ENGINEER
* Witness vendor IQ/OQ.
* Write and ensure validation plan is reviewed/approved/effective.
* Review applicable compendia (e.g., USP, EP, JP, CP) to ensure requirements will be carried during validation, vendor/software supplier, risk and ERES assessments will be performed as well as identifying specific procedures to be followed and what deliverables to be delivered.
* Work in a team effort in collaboration with system owner, QA, STS-IV and BT (as applicable).
* Write and ensure instrument/systemrequirements specification is reviewed/approved/effective in PDOCS.
* Write and ensure instrument/system site IQ/OQ/PQ protocols is reviewed/approved/effective in PDOCS, and to ensure the IQ/OQ/PQ protocols is executed successfully with supporting results and conclusion.
* If any deviation(s) encountered, deviation procedures will be followed to resolve deviation(s).
* Write applicable SOPs to ensure instrument/system operation, maintenance and system admin.
* Small project execution.
* General Operations Support.
* Documentation generation (specifications, protocols, etc).
* Support of maintenance of operation equipment.
* BS or MS degree in engineering or other scientific background.
* 3-5 years of experience is required.
* Should be familiar with biopharmaceutical equipment (bioreactors, ultrafiltration systems, etc) if possible and must have good GMP knowledge.
* Work well independently as well as in a team.