Pharmaceutical Validation Engineer

Placements24; Graafwater; On-site; ZAR 550,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Performance incentives

Career development

Job summary

Placements24 represents a leading pharmaceutical manufacturer hiring a Pharmaceutical Validation Engineer in Paarl, Western Cape. You will plan, execute, and document validation activities to ensure manufacturing processes and equipment meet cGMP and regulatory expectations.

The role demands strong analytical skills, technical writing, and the ability to work independently within a cross-functional team. You will develop validation master plans (VMPs), IQ/OQ/PQ protocols, and reports, maintain

Qualifications

• Bachelor's degree in Engineering or related scientific field.
• 4+ years in validation engineering within pharma/biotech/medical devices.
• Strong knowledge of cGMP, ICH guidelines, and FDA/EMA requirements.
• Experience with IQ/OQ/PQ protocols and documentation.

Responsibilities

• Develop and execute validation master plans, protocols, and reports.
• Perform IQ/OQ/PQ qualification activities for equipment and processes.
• Write, review, and approve validation documentation for compliance.
• Collaborate with cross-functional teams to define validation needs.
• Investigate deviations and ensure data traceability.
• Maintain validation records and support audits.

Skills

Validation engineering

IQ/OQ/PQ protocols

cGMP & regulatory

Equipment qualification

Process validation

Technical writing

Analytical skills

Independent worker

Team collaboration

Education

Bachelor's degree in Engineering or related field

Tools

Validation software

MS Office

QA systems

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a diligent Pharmaceutical Validation Engineer to join their team in Paarl, Western Cape . This role is essential for ensuring that all manufacturing processes, equipment, and systems meet stringent quality and regulatory standards. You will be responsible for planning, executing, and documenting validation activities to guarantee the reliability and consistency of pharmaceutical production. The ideal candidate has a solid understanding of validation principles, regulatory requirements, and possesses strong technical and analytical skills. This is a fantastic opportunity to contribute to a company dedicated to producing high-quality pharmaceuticals in the beautiful region of Paarl, Western Cape .

Key Responsibilities

• Develop and execute validation master plans (VMPs), protocols, and reports for manufacturing equipment, cleaning processes, utilities, and analytical methods.
• Perform qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Write, review, and approve validation protocols and reports, ensuring compliance with cGMP and regulatory guidelines.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality Assurance, QC) to define validation requirements and ensure successful execution.
• Investigate deviations and out-of-specification results during validation studies and recommend corrective actions.
• Maintain all validation documentation and ensure traceability of data.
• Stay current with industry best practices and regulatory expectations related to pharmaceutical validation.
• Participate in internal and external audits, providing expertise on validation activities.
• Assist in the development and implementation of change control processes for validated systems.
• Ensure that all validation activities are completed on time and within budget.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Biomedical) or a related scientific field.
• Minimum of 4 years of experience in validation engineering within the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of cGMP, ICH guidelines, and FDA/EMA regulatory requirements for validation.
• Demonstrated experience in equipment qualification, process validation, and cleaning validation.
• Proficiency in authoring and executing IQ/OQ/PQ protocols.
• Excellent technical writing skills, with the ability to produce clear, concise, and accurate documentation.
• Strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within a team environment.
• Proficiency in Microsoft Office Suite and familiarity with validation management software is a plus.

Benefits

Our client offers a competitive salary package, comprehensive health insurance, a retirement savings plan, performance-based incentives, and numerous opportunities for professional development and career growth. You will be working in a modern facility located in the picturesque town of Paarl, Western Cape , enjoying a great work-life balance.