CSV Engineer Job at Vastek Inc.
Job Title :
CSV EngineerDuration : 11 Month ContractLocation
MA (Onsite from day 1)MUST HAVE:
- Perform periodic review (audit trail and Computer system) for various computerized system (this includes HPLC, Nanodrop, WFI system, etc)
- Perform 21 CFR part 11 assessments for new systems. Client has approved forms that will be used for these assessments.
- Draft, execute test scripts for any changes to the computerized systemsJOB DESCRIPTION:
- 2 to 6 years of Computer System Validation with experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
- Direct experience within the following areas: Computer System Validation (CSV), Data Integrity, 21CFR Part 11, ERES, Enterprise Systems Qualification, Master Validation Plans, Standard Operating Procedure (SOP), Change Control, Data Analysis, Deviations, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM).
Thanks
Satish Mishra
Job Types: Full-time, Contract
Pay: From $37.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Agawam, MA 01001: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location
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