U.S. VALIDATION SERVICES LLC JOBS
US Validation Services LLC is looking for
Entry Level Validation Engineer and
Senior Level Validation Engineer to perform qualification of equipment and utility systems.
We have 6 -- 12 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 LLC is not sponsoring H1B visa program. Authorization to work in Unites States is Required.
ENTRY LEVEL VALIDATION ENGINEER:
Job Description:
- Execute previously approved Qualification Protocols and provide support during protocol executions.
- Setting up Temperature Data Acquisition equipment (KAYE Validator)
- Perform Temperature Mapping studies for Environmental Chambers
- Collect and Analyze data accumulated during temperature mapping studies
- Draft Summary Reports and applicable protocol amendments.
Qualifications:
- BS in chemical, biomedical, or mechanical engineering or relevant discipline
- Recent graduates, interns and coop students are welcome
- Ability to learn regulated by FDA production environment.
- Strong technical skills - ability to operate equipment and setup thermocouple wires
- 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.
SENIOR VALIDATION ENGINEER:
Job Description:
- Write Qualification protocols (IQ/OQ/PQ) for Equipment and Utility Systems
- Develop User Requirements and Functional Specifications
- Author Summary Reports and applicable protocol amendments.
- Execute Qualification Protocols and/or provide support during protocol executions.
- Write and investigate Discrepancies and Deviation Reports 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 at client's request
Qualifications:
- BS/MS in chemical or mechanical engineering or relevant discipline
- 5 to 7 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.