| VALIDATION ENGINEER II Gaithersburg, MD (Onsite) at Gaithersburg, Maryland, USA |
| Email: [email protected] |
| Please share resume at [email protected] ROLE VALIDATION ENGINEER INDUSTRY Life Sciences DURATION 4+ month Contract, probable extension LOCATION ONSITE reporting to Gaithersburg, MD 20878 Position Details Location: Gaithersburg, MD (100% Onsite) Contract Length: 4 Months + possible extensions pending performance and client need Responsibilities:- o Develop comprehensive protocols for the qualification/requalification of new and existing QM micro and QC analytical equipment. o Develop comprehensive protocols for the qualification of required clean utilities to service new QC Micro and QC analytical laboratory. o Develop comprehensive protocols for the qualification of new EMS monitoring points for CTUs and equipment alarming. o Ensure protocols adhere to in 21CFR Part 211 and EU Annex 1 and are aligned with quality policies, procedures, and the Validation Master Plan (VMP) of the Gaithersburg site. o Implement and execute protocols/test scripts for the qualification of equipment, including but not limited to temperature mapping and installation, operational, and performance qualification verifications. o Coordinate with relevant BNT stakeholders CQV manager and BNT CQV lead to execute protocols/test scripts efficiently. o Document qualification results and provide recommendations for any necessary adjustments or corrective actions. o Conduct thorough reviews of executed protocols to ensure completeness and accuracy. o Address and generate any discrepancies, exceptional conditions or deviations identified during the review/execution process. Required Experience: o Minimum of 2-3 years of hands-on experience in equipment qualification, including protocol development, execution, and review. o Familiarity with equipment qualification processes (IQ, OP, and PQ), including temperature mapping using Kaye AVS and Kaye Val probes. o Proven record of delivering projects on time and within budget while adhering to regulatory requirements. o Demonstrated understanding of regulatory requirements relevant to equipment qualification in the biotech or pharmaceutical industry, including cGMP, GLP, and GAMP guidelines. o Minimum of a bachelors degree in a scientific field such as Biology, Chemistry, Biochemistry, Engineering, or related discipline. Thanks and Regards!! Akashika Pandey Technical Resource Specialist Ace Technologies Inc 2375 Zanker Road, Suite 250, San Jose, CA 95131 Phone: 408-442-3665 | Extn 4286 | Email ID/Hangout : [email protected] ------------------------------------------------------------------------------------------------------- Reporting Manager: Gaurav Kumar| Email ID : Gauravk @acetechnologies.com | Phone: 408-442-3665 Ext 4261 Escalations : [email protected] Note: We respect your Online Privacy. This is not an unsolicited mail. Under Bills.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered unsolicited as long as we include Contact information and a method to be removed from our mailing list. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line to [email protected] and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience -- Keywords: information technology California Idaho Maryland |
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| Fri Mar 22 00:36:00 UTC 2024 |