Validation Engineer
Job in
Ellicott City, Howard County, Maryland, 21042, USA
Listed on 2026-08-04
Listing for:
United Pharma
Full Time
position Listed on 2026-08-04
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
We are seeking an experienced Validation Engineer to support commissioning, qualification, and computer system validation activities within a cGMP biopharmaceutical manufacturing environment. The ideal candidate will manage validation projects from concept through performance qualification while ensuring regulatory compliance and supporting manufacturing operations.
Key Responsibilities- Lead equipment, utility, facility, and computer system validation projects from planning through execution.
- Author, review, and execute IQ/OQ/PQ protocols, validation reports, and lifecycle documentation.
- Support Commissioning & Qualification (C&Q) and Computer System Validation (CSV) activities.
- Validate bulk drug substance manufacturing equipment in single-use facilities.
- Review URS, FS, DS, commissioning documents, and validation deliverables.
- Support process improvements, temperature mapping, and compliance with cGMP/GxP requirements.
- Collaborate with Engineering, Manufacturing, MSAT, QA, and cross-functional teams to ensure successful project execution.
- Bachelor's degree in Engineering, Science, or a related field.
- 5+ years of validation experience in biopharmaceutical or biotech manufacturing.
- Strong experience with equipment qualification, CSV, IQ/OQ/PQ, and process validation.
- Knowledge of cGMP, GxP, validation lifecycle, and regulatory requirements.
- Experience with DeltaV, LIMS, MES, or similar validated systems preferred.
- Excellent technical writing, communication, and problem-solving skills.
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