8 Onsite Work - Need Validation Engineer in Gaithersburg MD Jobs in Gaithersburg, MD
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Onsite Work - Need Validation Engineer in Gaithersburg MD
$117k-135k (estimate)
Full Time
1 Month Ago
Steneral Consulting is Hiring an Onsite Work - Need Validation Engineer in Gaithersburg MD Near Gaithersburg, MD
100% onsite in Gaithersburg, MD Must be local and under 60-70 misNeed valid LinkedInMust be w2 or 1099Responsibilities
- Develop comprehensive protocols for the qualification/requalification of new and existing QM micro and QC analytical equipment.
- Develop comprehensive protocols for the qualification of required clean utilities to service new QC Micro and QC analytical laboratory.
- Develop comprehensive protocols for the qualification of new EMS monitoring points for CTUs and equipment alarming.
- 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.
- 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.
- Coordinate with relevant BNT stakeholders CQV manager and BNT CQV lead to execute protocols/test scripts efficiently.
- Document qualification results and provide recommendations for any necessary adjustments or corrective actions.
- Conduct thorough reviews of executed protocols to ensure completeness and accuracy.
- Address and generate any discrepancies, exceptional conditions or deviations identified during the review/execution process.
- Minimum of 2-3 years of hands-on experience in equipment qualification, including protocol development, execution, and review.
- Familiarity with equipment qualification processes (IQ, OP, and PQ), including temperature mapping using Kaye AVS and Kaye Val probes.
- Proven record of delivering projects on time and within budget while adhering to regulatory requirements.
- Demonstrated understanding of regulatory requirements relevant to equipment qualification in the biotech or pharmaceutical industry, including cGMP, GLP, and GAMP guidelines.
- Minimum of a bachelor’s degree in a scientific field such as Biology, Chemistry, Biochemistry, Engineering, or related discipline.
Job Summary
JOB TYPE
Full Time
SALARY
$117k-135k (estimate)
POST DATE
06/02/2024
EXPIRATION DATE
09/22/2024
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