Pharma Validation Engineer Lead: IQ/OQ/PQ & Compliance

Placements24; Queenstown; Híbrido; NZD 96 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary package

Professional development

Relocation assistance

Resumo da oferta

Placements24 is seeking a Senior Pharmaceutical Validation Engineer for a role in Queenstown, Eastern Cape. The candidate will lead validation strategy, develop VMPs, and execute IQ/OQ/PQ across equipment, processes, facilities, and utilities to ensure cGMP compliance.

The ideal candidate has 6–8 years of pharma/biotech validation, strong analytical and writing skills, and ability to collaborate with engineering, manufacturing, QA, and R&D teams. Relocation support may be available.

Qualificações

• Bachelor's degree in Engineering or related field.
• Minimum 6–8 years in pharmaceutical/biotech validation.
• Strong knowledge of cGMP, ICH guidelines and regulatory expectations.
• Experience with IQ/OQ/PQ protocols and validation reports.
• Excellent technical writing and cross-functional collaboration skills.

Responsabilidades

• Develop VMPs and validation protocols for equipment, processes, facilities, and utilities.
• Execute IQ, OQ, PQ protocols and analyze validation data.
• Prepare detailed validation reports and manage deviations/change controls.
• Ensure validation activities comply with cGMP, GAMP, FDA/EMA/SAPRA guidelines.
• Collaborate with Engineering, Manufacturing, QA, and R&D for validation needs.
• Maintain audit-ready validation documentation and records.
• Perform risk assessments to identify critical process parameters.
• Assist in design/qualification of new equipment and facilities.
• Stay updated on regulatory expectations and validation best practices.
• Provide guidance on validation matters to project teams and site personnel.
• Review validation docs from vendors/consultants and support audits.

Conhecimentos

Validation strategy development

IQ/OQ/PQ execution

Analytical problem solving

Regulatory compliance

Technical writing

Cross-functional collaboration

Formação académica

Bachelor's degree in Engineering

Pharmaceutical/biotech validation experience

Ferramentas

PLC/SCADA validation

Descrição da oferta de emprego

Placements24 is seeking a Senior Pharmaceutical Validation Engineer for a role in Queenstown, Eastern Cape. The candidate will lead validation strategy, develop VMPs, and execute IQ/OQ/PQ across equipment, processes, facilities, and utilities to ensure cGMP compliance.

The ideal candidate has 6–8 years of pharma/biotech validation, strong analytical and writing skills, and ability to collaborate with engineering, manufacturing, QA, and R&D teams. Relocation support may be available.