Remote Pharmaceutical Validation Engineer

Placements24; Upington; Hybrid; ZAR 482,000 - 758,000; Full time

Job summary

Placements24 is hiring a Remote Pharmaceutical Validation Engineer for a contract role in South Africa. You will plan, execute, and document validation activities for equipment, processes, utilities, and CSV, ensuring compliance with regulatory standards while working remotely across the country.

The ideal candidate has 4+ years in pharmaceutical validation, strong technical writing, and a thorough understanding of IQ/OQ/PQ and GAMP 5. Remote collaboration with multiple departments is required.

Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical), Computer Science, or a related field.
• Minimum 4 years of experience in pharmaceutical validation (equipment, process, utility, CSV).
• Thorough understanding of validation principles, IQ/OQ/PQ, and the GAMP 5 methodology.
• Strong technical writing and documentation skills; ability to work remotely.

Responsibilities

• Develop validation master plans (VMPs) and individual validation protocols (IQ, OQ, PQ).
• Execute validation protocols and document results meticulously.
• Write comprehensive validation reports with required data and analyses.
• Identify deviations and propose corrective actions.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines.
• Review and approve validation documentation from team members.
• Participate in validation-related audits and inspections.
• Collaborate with engineering, manufacturing, QA, and IT.
• Stay current with industry best practices and regulatory expectations.
• Manage multiple validation projects in a remote setting.

Skills

Technical writing

Analytical

Independent work

Project management

Education

Bachelor's degree in Engineering/Computer Science

Tools

GAMP 5

IQ/OQ/PQ

CSV

Job description

About the Role

Our client, a dynamic pharmaceutical company focused on innovation, is seeking a skilled Remote Pharmaceutical Validation Engineer. This is a contract position offering the flexibility to work remotely from anywhere in South Africa. You will be responsible for the planning, execution, and documentation of validation activities for equipment, processes, utilities, and computer systems used in pharmaceutical manufacturing. The goal is to ensure that all validated systems consistently produce results meeting predetermined specifications and quality attributes, adhering strictly to regulatory standards. The ideal candidate is detail-oriented, possesses strong technical writing skills, and has a comprehensive understanding of validation principles within the pharmaceutical industry. This role is perfect for an experienced professional seeking project-based work with remote flexibility.

Key Responsibilities

• Develop validation master plans (VMPs) and individual validation protocols (IQ, OQ, PQ).
• Execute validation protocols and document results meticulously.
• Write comprehensive validation reports, ensuring all required data and analyses are included.
• Identify and address deviations during validation activities and propose effective corrective actions.
• Ensure all validation activities comply with cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Review and approve validation documentation from other team members.
• Participate in validation-related audits and inspections.
• Collaborate with engineering, manufacturing, quality assurance, and IT departments.
• Stay current with industry best practices and regulatory expectations for validation.
• Manage multiple validation projects efficiently in a remote setting.

Requirements

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical), Computer Science, or a related field.
• Minimum of 4 years of experience in pharmaceutical validation (equipment, process, utility, CSV).
• Thorough understanding of validation principles, IQ/OQ/PQ, and the GAMP 5 methodology.
• Proficiency in developing and executing validation protocols and reports.
• Strong technical writing and documentation skills.
• Knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements.
• Excellent analytical and problem-solving abilities.
• Ability to work independently and manage project timelines effectively in a remote environment.
• Experience with Computer System Validation (CSV) is highly desirable.
• Must have a dedicated home office space with reliable internet connectivity.

Benefits

This contract role offers a competitive daily or hourly rate, commensurate with experience. As a remote contractor, you will enjoy significant flexibility in your work schedule. Our client provides clear project scopes and timely payments, facilitating a smooth working relationship. This is an excellent opportunity to leverage your validation expertise on challenging projects within the pharmaceutical sector, contributing to the development of essential medicines.