More jobs:
Validation Engineer/Validation Specialist
Job in
Fort Washington, Prince George's County, Maryland, 20749, USA
Listed on 2026-07-27
Listing for:
Stark Pharma Solutions Inc
Seasonal/Temporary
position Listed on 2026-07-27
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Hi, I am Karthik Mutyala from Stark Pharma Solutions Inc. We are hiring talents for our client. I am working on Validation Engineer right now. If you are interested you may contact me.
PositionValidation Engineer / Validation Specialist
LocationMaryland
DurationLong‑Term Contract
Job OverviewWe are seeking an experienced Validation Engineer / Validation Specialist to support equipment, utilities, and facility qualification activities in a GMP‑regulated pharmaceutical/biotechnology manufacturing environment. The ideal candidate will have hands‑on experience executing validation protocols and supporting commissioning, qualification, and compliance initiatives.
Key Responsibilities- Develop, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for manufacturing equipment and utilities.
- Prepare validation reports, SOPs, risk assessments, gap analyses, and technical documentation following GDP and cGMP requirements.
- Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
- Analyze validation data and investigate deviations to ensure compliance with acceptance criteria.
- Support commissioning, FAT/SAT, equipment startup, and qualification activities.
- Assist with audits and provide technical support for manufacturing and validation investigations.
- Review validation documentation and collaborate with Engineering, Manufacturing, Quality, and Maintenance teams.
- Bachelor's degree in Engineering or a related scientific discipline with 4+ years of validation experience, or 8+ years of relevant validation experience without a degree.
- Hands‑on experience in GMP pharmaceutical or biotechnology manufacturing.
- Strong knowledge of IQ/OQ/PQ, cGMP, GDP, and validation lifecycle.
- Experience with aseptic processing, clean rooms, sterilization equipment, and critical utilities (HVAC, WFI, RO, compressed air, etc.).
- Familiarity with Kaye AVS, Veriteq, EDMS, LIMS, Microsoft Office, and related validation systems.
- Excellent troubleshooting, documentation, and communication skills.
- Ability to manage multiple projects independently and in a team environment.
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