Validation Engineer

Hw3 Llc; North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

Hw3 Llc is seeking an experienced validation lead for pharmaceutical/biopharmaceutical environments. The role involves directing validation activities across multiple projects, authoring key qualification documents, and ensuring adherence to GMP and regulatory standards.

The candidate will manage DQ/IQ/OQ/PQ and Process Validation efforts, support commissioning/qualification, and document deviations and change controls while maintaining rigorous record-keeping in Veeva Vault, QualityDocs, and

Qualifications

• 15+ years of professional experience in pharma/biopharma environments.
• Experience leading validation activities across projects and areas such as aseptic formulation and filling, manufacturing equipment, packaging, device assembly, laboratory/GMP facilities, IT systems, warehouse and QC.

Responsibilities

• Lead validation activities across multiple projects.
• Author and execute DQ, IQ, OQ, PQ and Process Validation.
• Develop, revise and maintain validation documentation including validation plans/reports, specifications, risk assessments, traceability matrices and decommissioning documentation.
• 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 records using Veeva Vault/QualityDocs and TIMS (HP ALM).
• Ensure validation activities comply with GMP, FDA, EU Annex 15, GAMP 5.

Skills

Validation leadership

GMP compliance

Project management

Independent work

Documentation

Tools

Veeva Vault

QualityDocs

TIMS HP ALM

Job description

• 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/QualityDocs 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