Pharmaceutical Validation Engineer

Placements24; East London; On-site; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Medical benefits

Retirement plan

Bonuses based on performance

Growth opportunities

Quality culture and continuous-improve

Job summary

Placements24 is seeking a meticulous Pharmaceutical Validation Engineer for their East London, Eastern Cape operation. You will develop, execute, and document validation protocols (IQ/OQ/PQ) for equipment, processes, cleaning, utilities, and computer systems, ensuring cGMP compliance and regulatory alignment.

You will collaborate with Engineering, Manufacturing, Quality Assurance, and Quality Control to define validation requirements, maintain documentation for audits, and support regulatory

Job description

About the Role

Our client, a reputable pharmaceutical manufacturing company, is seeking a meticulous and experienced Pharmaceutical Validation Engineer to join their team in **East London, Eastern Cape**. This role is critical for ensuring that all manufacturing processes, equipment, facilities, and utility systems meet stringent regulatory standards and are validated for their intended use. The Validation Engineer will be responsible for developing, executing, and documenting validation protocols, ensuring compliance with cGMP and other relevant regulations. This is a significant opportunity for a detail-oriented engineer to contribute to the quality and integrity of pharmaceutical production in **East London, Eastern Cape**. The **East London, Eastern Cape** location offers a robust industrial environment.

Key Responsibilities

• Develop comprehensive validation master plans (VMPs) and individual validation protocols (IQ, OQ, PQ) for equipment, processes, cleaning, utilities, and computer systems.
• Execute validation protocols, meticulously documenting all activities and results.
• Analyze validation data, prepare validation reports, and manage deviations or out-of-specification (OOS) results encountered during validation activities.
• Ensure all validation activities are conducted in compliance with current Good Manufacturing Practices (cGMP), FDA, EMA, SAHPRA, and other relevant regulatory requirements.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and Quality Control departments to define validation requirements and ensure smooth execution.
• Maintain validation documentation and ensure it is readily available for audits and inspections.
• Participate in the review of change controls and assess the impact on existing validations.
• Stay current with industry best practices, regulatory guidelines, and emerging technologies in validation.
• Support regulatory inspections and audits by providing necessary documentation and explanations related to validation activities.

Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field), or a related scientific discipline.
• Minimum of 4-6 years of experience in validation engineering within the pharmaceutical or biotechnology industry.
• In-depth knowledge of validation principles and practices, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Thorough understanding of cGMP regulations and guidelines relevant to pharmaceutical manufacturing.
• Experience with validation of various types of pharmaceutical equipment (e.g., reactors, filling machines, lyophilizers) and processes.
• Proficiency in developing and executing validation protocols and reports.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and as part of a cross-functional team.

Benefits

• Our client offers a competitive salary
• comprehensive medical and retirement benefits
• performance-based bonuses
• opportunities for professional growth through training and development programs
• The company fosters a culture of quality and continuous improvement, providing a supportive environment for its employees.
• This role is crucial for ensuring product quality and regulatory compliance, offering a stable and rewarding career path.
• The **East London, Eastern Cape** location provides a solid foundation for engineering professionals.