Validation Engineer

Placements24; Vereeniging; On-site; ZAR 600,000 - 800,000; Full time

Job summary

Placements24 is seeking a detail-oriented Validation Engineer to join our Vereeniging facility. You will plan, execute, and document validation activities (IQ, OQ, PQ, CSV) for pharmaceutical equipment and processes, ensuring compliance with GMP and regulatory standards.

You will collaborate with Engineering, Manufacturing and QA teams, maintaining thorough documentation for inspections and audit readiness.

Qualifications

• Bachelor-level engineering degree required (Mechanical, Electrical, Chemical or related).
• 3–5 years of validation experience in pharma or regulated industry.
• Strong understanding of validation principles and regulatory requirements (FDA/EMA/SAHPRA).
• Experience with Computer System Validation (CSV) is highly desirable.
• Excellent documentation and ability to work independently and in a team.

Responsibilities

• Develop and execute validation master plans (VMP) and protocols (IQ/OQ/PQ/CSV).
• Perform validation activities in compliance with GMP and regulatory expectations.
• Write validation reports with conclusions and summaries.
• Collaborate with Engineering, Manufacturing and QA to ensure smooth validation processes.
• Maintain validation documentation for regulatory inspections.
• Investigate deviations and troubleshoot validation issues.

Skills

GMP knowledge

Validation experience

Documentation skills

CSV experience

Teamwork

Education

Bachelor's degree in Engineering

Job description

About the Role

Our client is looking for a detail-oriented Validation Engineer to join their facility in Vereeniging . This role is crucial for ensuring that all pharmaceutical manufacturing equipment, processes, and systems meet stringent regulatory requirements and are fit for their intended purpose. You will be responsible for planning, executing, and documenting validation activities, including IQ, OQ, PQ, and CSV. The successful candidate will have a strong understanding of GMP, validation principles, and a meticulous approach to documentation. Your work will directly contribute to the safety, efficacy, and compliance of the pharmaceutical products manufactured by our client.

Key Responsibilities

• Develop and execute validation master plans (VMP) and associated protocols (IQ, OQ, PQ, CSV) for pharmaceutical equipment, utilities, and processes.
• Perform validation activities in compliance with GMP guidelines and regulatory expectations.
• Write comprehensive validation reports, summarizing results and providing conclusions.
• Collaborate with Engineering, Manufacturing, and Quality Assurance departments to ensure seamless validation processes.
• Maintain validation documentation and ensure its readiness for regulatory inspections.
• Investigate and troubleshoot any deviations or issues encountered during validation activities.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical) or a related scientific field.
• Minimum of 3-5 years of experience in validation within the pharmaceutical or related regulated industry.
• Thorough understanding of validation principles, cGMP , and regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Experience with Computer System Validation (CSV) is highly desirable.
• Strong documentation skills and attention to detail.
• Ability to work independently and as part of a team.

Benefits

• Competitive annual salary and potential for overtime pay.
• Comprehensive medical and retirement benefits.
• Opportunities for professional development and specialized validation training.
• Work within a reputable pharmaceutical company known for its commitment to quality.
• Generous annual leave and employee wellness programs.