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Validation Engineer
Job in
High Point, Guilford County, North Carolina, 27260, USA
Listed on 2026-10-30
Listing for:
Hw3 Llc
Full Time
position Listed on 2026-10-30
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- Experience: 15+ years of professional experience, ideally within pharmaceutical/biopharmaceutical environments
- Lead validation activities across multiple projects within areas such as aseptic formulation and filling, manufacturing equipment, packaging, device assembly, laboratory/GMP facilities, IT systems, warehouse and QC
- Develop, revise and maintain key validation documentation including Validation Plans/Reports, specifications, risk assessments, traceability matrices and decommissioning documentation
- Author and execute DQ, IQ, OQ, PQ and Process Validation activities
- Support Commissioning & Qualification
, including FAT activities where required - Identify, investigate and document deviations and engineering changes encountered during validation
- Initiate/support Change Controls and assess validation impact
- Maintain validation and change-control records using systems such as Veeva Vault/Quality Docs and TIMS (HP ALM)
- Ensure validation activities comply with GMP, FDA, EU Annex 15, GAMP 5 and company procedures
- Experience with one or more of the following is particularly valuable:
SCADA, PLC, PAS-X, LMES/MES, process instrumentation, BMS/HVAC, utilities, electrical systems, security/access control, CCTV, manufacturing equipment and technology modernization - Candidates should be comfortable working independently, leading validation activities and providing regular project updates to Project Managers
- Some evening/weekend work may be required during larger projects or plant shutdowns
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