Validation Engineer - Kimberley

Placements24; Noord-Kaap; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund

Paid vacation

Sick leave

Professional development

Job summary

Placements24 is seeking a diligent Validation Engineer in Kimberley, SA, to ensure manufacturing equipment, processes and facilities meet regulatory and quality standards. You will plan, execute and document validation activities including IQ, OQ and PQ for equipment and systems.

The role requires a Bachelor's degree in Engineering and 3+ years in validation within pharmaceutical or related industries, with strong GMP knowledge and meticulous technical writing skills.

Qualifications

• Bachelor's degree in Engineering required.
• 3+ years in validation in pharma/biotech/medical devices.
• Strong understanding of GMP principles and validation methods (IQ/OQ/PQ).
• Experience with process validation and equipment/cleanroom qualification.
• Excellent technical writing and teamwork skills.

Responsibilities

• Develop and execute validation master plans for equipment, processes and utilities.
• Perform IQ, OQ and PQ activities.
• Generate comprehensive validation reports with findings and actions.
• Ensure validation activities comply with cGMP, FDA and other regulatory guidelines.
• Collaborate with Engineering, Manufacturing and QA teams to support validation.
• Maintain validation documentation and periodic revalidations.

Skills

Technical writing

Problem-solving

Teamwork

GMP knowledge

IQ/OQ/PQ understanding

Education

Bachelor's degree in Engineering

Job description

About the Role

Our client is seeking a diligent and experienced Validation Engineer to join their expanding operations in Kimberley. This critical role ensures that all manufacturing equipment, processes, and facilities meet stringent regulatory and quality standards within the pharmaceutical industry. You will be responsible for planning, executing, and documenting validation activities, including IQ, OQ, and PQ, for equipment and systems. The ideal candidate possesses a strong technical background, a deep understanding of GMP principles, and meticulous attention to detail to ensure compliance and product quality.

Key Responsibilities

• Develop and execute validation master plans (VMPs) and associated protocols for equipment, processes, and utilities.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Generate comprehensive validation reports, summarizing findings and recommending actions.
• Ensure all validation activities comply with cGMP, FDA, and other relevant regulatory guidelines.
• Collaborate with Engineering, Manufacturing, and Quality Assurance teams to support validation efforts.
• Maintain validation documentation and ensure systems remain in a validated state through periodic reviews and revalidation.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical) or a related scientific field.
• Minimum of 3 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
• Thorough understanding of GMP principles and validation methodologies (IQ/OQ/PQ).
• Experience with process validation, equipment qualification, and cleanroom validation.
• Strong technical writing skills and the ability to document complex procedures clearly.
• Excellent problem-solving skills and ability to work effectively within a team.

Benefits

• Competitive salary and performance bonus opportunities.
• Opportunity to work in a growing pharmaceutical manufacturing site.
• Comprehensive medical aid and retirement fund.
• Generous paid vacation and sick leave.
• Support for professional development and training.