Senior Pharmaceutical Validation Engineer

Placements24; Southampton; Hybrid; GBP 40,000 - 54,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Training & conferences

Relocation assistance

Paid leave

Job summary

Placements24 is seeking a Senior Pharmaceutical Validation Engineer to join our client in Randburg. You will lead validation programs for equipment, processes, facilities, and computer systems, ensuring cGMP compliance and regulatory readiness.

The role requires 5–7 years in validation engineering, strong risk-based thinking, and the ability to drive documentation and audits. A medical-grade manufacturing environment and cross-functional collaboration are essential.

Qualifications

• Bachelor degree in a relevant engineering discipline and 5–7 years in validation engineering.
• Strong understanding of FDA cGMP, audits, and validation lifecycle.
• Experience developing and executing VMPs, IQ/OQ/PQ, and related reports.

Responsibilities

• Develop, review, and execute validation master plans and protocols.
• Ensure validation activities meet cGMP, FDA, EMA guidelines.
• Collaborate with cross-functional teams to define validation requirements.
• Perform risk assessments and implement mitigation strategies.
• Maintain validation documentation and support regulatory inspections.
• Provide expert guidance on validation issues to internal teams.

Skills

Validation engineering

cGMP & regulatory

Risk-based validation

Analytical skills

Project leadership

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electrical Engineering

Job description

About the Role

Our client, a respected leader in the pharmaceutical manufacturing sector, is seeking a highly experienced Senior Pharmaceutical Validation Engineer to join their esteemed team in Randburg . This vital role ensures that all manufacturing equipment, processes, facilities, and utilities comply with cGMP and other regulatory requirements through rigorous validation protocols. The ideal candidate will possess a strong engineering foundation combined with extensive knowledge of validation principles and pharmaceutical industry best practices. You will be instrumental in developing and executing validation master plans, protocols, and reports, ensuring product quality and patient safety. This is an exceptional opportunity to apply your expertise within the dynamic pharmaceutical landscape of Gauteng , specifically in Randburg . We are looking for a meticulous and proactive individual who can lead validation projects and contribute to a culture of compliance and operational excellence.

Key Responsibilities

• Develop, review, and execute validation master plans (VMPs), protocols (IQ, OQ, PQ), and reports for manufacturing equipment, utility systems, processes, and computer systems.
• Ensure all validation activities are conducted in compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance, IT) to define validation requirements and strategies.
• Perform risk assessments related to validation activities and implement appropriate mitigation strategies.
• Investigate deviations and out-of-specification (OOS) results during validation studies and recommend corrective actions.
• Maintain all validation documentation and records in an organized and compliant manner.
• Provide technical expertise and guidance on validation-related issues to internal teams and external vendors.
• Support regulatory inspections and audits by providing validation documentation and expertise.
• Stay updated on current validation technologies, methodologies, and regulatory expectations.
• Contribute to the continuous improvement of the validation program and related SOPs.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
• Minimum of 5-7 years of experience in validation engineering within the pharmaceutical, biotechnology, or medical device industry.
• Thorough understanding of cGMP regulations and validation principles (e.g., FDA 21 CFR Part 11, GAMP 5).
• Proven experience in developing and executing validation protocols for equipment, processes, facilities, and computer systems.
• Strong knowledge of risk-based approaches to validation.
• Excellent analytical, problem-solving, and decision-making skills.
• Effective written and verbal communication skills, with the ability to prepare clear and concise technical reports.
• Ability to manage multiple projects simultaneously and meet deadlines.
• Proficiency in using standard office software and relevant validation/quality management systems.
• Experience with sterile product manufacturing validation is a significant advantage.

Benefits

Our client offers a competitive salary, performance incentives, and a comprehensive benefits package, including excellent medical, dental, and vision insurance, and a retirement savings plan. We are committed to your career development through access to specialized training, industry conferences, and opportunities for advancement. Generous annual leave, paid sick leave, and public holidays are standard. Additional benefits include life insurance, disability coverage, and potential relocation assistance for qualified candidates moving to Randburg . Join a leading pharmaceutical company and contribute to the integrity and compliance of critical manufacturing processes.