COMMISSIONING VALIDATION ENGINEER
We are seeking for Commissioning/Validation Engineer to perform qualification of equipment and utility systems.
We have a 3 to 6 month project in Boston area where we are assisting our pharmaceutical client.
Please send us your resume to: JOBS@USVALIDATION.COM
Please note that U.S.Validation Services, Inc. is not sponsoring H1B visa program. Authorization to work in Unites States is Required.
- Write Equipment/Facility/Utility and Instrument Qualification protocols (IQ/OQ/PQ)
- Develop User Requirements and Functional Specifications
- Author Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- Write and investigate Discrepancies and Deviations which occurs during execution of the Qualification Protocols
- Assure all the qualification items are tracked and successfully completed.
- Coloborate with Metrology department to assure that all instruments related to equipment are in calibrated state during execution of the protocols.
- Develop Operation and Preventative Maintenance procedures
- BS/MS in chemical or mechanical engineering or relevant discipline
- 3 to 5 years of experience working within cGMP regulated production environment.
- Must have a working knowledge of cGMP type systems and practices (21CFR Part 210 and 211 and ICH Q7)
- Strong technical writing and documentation skills are required.
- Must demonstrate strong interpersonal and teamwork skills.
- Authorization to work in Unites States is Required.
- Ability to work in a fast pace environment.