Pharmaceutical Validation Engineer

Placements24; Vereeniging; Hybrid; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Generous annual leave

Retirement savings plan

Training & development

Job summary

Placements24 seeks a Pharmaceutical Validation Engineer for its Vereeniging facility to ensure manufacturing processes, equipment, and utilities meet GMP and regulatory standards through comprehensive validation.

You will develop and execute validation protocols (IQ/OQ/PQ), manage validation projects, write reports, and collaborate with Engineering, Manufacturing, QA, and QC to support quality and continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 4+ years of validation experience in pharmaceutical/biotech/medical devices.
• Strong knowledge of IQ/OQ/PQ and GMP expectations.
• Experience writing and executing validation protocols and reports.
• Excellent documentation and attention to detail.
• Proven project management and cross-functional communication skills.
• Experience with process automation and control systems is a plus.

Responsibilities

• Develop, execute, and document validation protocols for manufacturing processes, equipment, analytical methods, cleaning procedures, and utilities.
• Write validation summary reports and ensure GMP/compliance.
• Participate in design/commissioning of new equipment and facilities with validation input.
• Manage validation projects including scope, resources, scheduling, and risk assessment.
• Conduct revalidation studies and assess impact of changes on validated systems.
• Investigate deviations and OOS results related to validation.
• Maintain validation documents and assist audits.
• Collaborate with Engineering, Manufacturing, QA, and QC teams.

Skills

IQ/OQ/PQ

GMP knowledge

Validation protocols

Documentation

Project management

Analytical skills

Communication

Education

Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or related field

Job description

About the Role

Our client, a leading pharmaceutical company committed to producing safe and effective medicines, is seeking a diligent and experienced Pharmaceutical Validation Engineer for their facility in Vereeniging . This crucial role involves ensuring that all manufacturing processes, equipment, facilities, and utilities meet stringent regulatory standards through comprehensive validation protocols. The Validation Engineer will play a key part in maintaining compliance with Good Manufacturing Practices (GMP) and other relevant guidelines, supporting the company's reputation for quality and reliability. This is an excellent opportunity for a technically proficient individual to contribute to critical quality assurance efforts in a dynamic pharmaceutical environment. The role demands a strong understanding of validation principles and regulatory expectations.

Key Responsibilities

• Develop, execute, and document validation protocols for manufacturing processes, equipment, analytical methods, cleaning procedures, and utilities (e.g., HVAC, water systems).
• Write validation summary reports and ensure all validation activities are completed in compliance with GMP and relevant regulatory guidelines (e.g., FDA, SAHPRA).
• Participate in the design and commissioning of new equipment and facilities, providing input on validation requirements.
• Manage validation projects, including scope definition, resource allocation, scheduling, and risk assessment.
• Conduct revalidation studies and evaluate the impact of changes on validated systems.
• Investigate deviations and out-of-specification (OOS) results related to validation activities.
• Maintain validation documentation and databases, ensuring they are up-to-date and readily available for audits.
• Collaborate with cross-functional teams including Engineering, Manufacturing, Quality Assurance, and Quality Control.
• Stay current with industry best practices and regulatory expectations for validation.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or a related scientific field.
• A minimum of 4 years of experience in validation within the pharmaceutical or related industry (e.g., biotechnology, medical devices).
• In-depth knowledge of validation principles (IQ/OQ/PQ) and methodologies.
• Familiarity with GMP regulations and guidelines relevant to pharmaceutical manufacturing and validation.
• Experience with writing and executing validation protocols and reports.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent documentation and record-keeping abilities.
• Proficiency in project management and effective communication skills.
• Experience with process automation and control systems is a plus.

Benefits

• Competitive salary based on experience and qualifications.
• Comprehensive health insurance coverage.
• Generous annual leave and company holidays.
• Retirement savings plan.
• Opportunities for professional growth and training.
• Exposure to diverse validation projects within the pharmaceutical industry.
• A culture that values quality, compliance, and continuous improvement.