Senior Pharmaceutical Validation Engineer

Placements24; Queenstown; Hybrid; NZD 96,000 - 160,000; Full time

Benefits offered by this job

Competitive salary package

Professional development

Relocation assistance

Job summary

Placements24 is seeking a Senior Pharmaceutical Validation Engineer for a role in Queenstown, Eastern Cape. The candidate will lead validation strategy, develop VMPs, and execute IQ/OQ/PQ across equipment, processes, facilities, and utilities to ensure cGMP compliance.

The ideal candidate has 6–8 years of pharma/biotech validation, strong analytical and writing skills, and ability to collaborate with engineering, manufacturing, QA, and R&D teams. Relocation support may be available.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 6–8 years in pharmaceutical/biotech validation.
• Strong knowledge of cGMP, ICH guidelines and regulatory expectations.
• Experience with IQ/OQ/PQ protocols and validation reports.
• Excellent technical writing and cross-functional collaboration skills.

Responsibilities

• Develop VMPs and validation protocols for equipment, processes, facilities, and utilities.
• Execute IQ, OQ, PQ protocols and analyze validation data.
• Prepare detailed validation reports and manage deviations/change controls.
• Ensure validation activities comply with cGMP, GAMP, FDA/EMA/SAPRA guidelines.
• Collaborate with Engineering, Manufacturing, QA, and R&D for validation needs.
• Maintain audit-ready validation documentation and records.
• Perform risk assessments to identify critical process parameters.
• Assist in design/qualification of new equipment and facilities.
• Stay updated on regulatory expectations and validation best practices.
• Provide guidance on validation matters to project teams and site personnel.
• Review validation docs from vendors/consultants and support audits.

Skills

Validation strategy development

IQ/OQ/PQ execution

Analytical problem solving

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Pharmaceutical/biotech validation experience

Tools

PLC/SCADA validation

Job description

About the Role

Our client is a dynamic pharmaceutical company dedicated to ensuring the highest standards of product quality and regulatory compliance. We are seeking a seasoned Senior Pharmaceutical Validation Engineer to join our expanding team in Queenstown, Eastern Cape . This role is essential for guaranteeing that our manufacturing processes, equipment, and facilities consistently produce safe and effective pharmaceutical products. You will be responsible for developing and executing validation strategies, protocols, and reports, ensuring adherence to cGMP and other relevant regulatory requirements. This is an excellent opportunity for a meticulous and experienced engineer to make a significant contribution to our operations and to grow professionally.

Key Responsibilities

• Develop comprehensive validation master plans (VMPs) and individual validation protocols for equipment, processes, facilities, and utilities.
• Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Analyze validation data, prepare detailed validation reports, and manage deviations and change controls related to validation activities.
• Ensure all validation activities are performed in compliance with cGMP, GAMP, FDA, EMA, SAHPRA, and other applicable regulatory standards.
• Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality Assurance, and R&D, to define validation requirements and ensure successful implementation.
• Maintain validation documentation and records in an audit-ready state.
• Conduct risk assessments to identify critical process parameters and potential validation challenges.
• Participate in the design and qualification of new equipment and facilities.
• Stay current with regulatory expectations and industry best practices in pharmaceutical validation.
• Provide technical expertise and guidance on validation-related matters to project teams and site personnel.
• Review and approve validation documentation generated by external vendors or consultants.
• Support regulatory inspections and audits by providing validation documentation and explanations.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or Pharmaceutical) or a related scientific field.
• A minimum of 6-8 years of experience in validation within the pharmaceutical or biotechnology industry.
• In-depth knowledge of validation principles and practices for pharmaceutical manufacturing processes, equipment, utilities, and facilities.
• Strong understanding of cGMP, ICH guidelines, and regulatory requirements related to validation.
• Proven experience in developing and executing IQ, OQ, PQ protocols.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in risk assessment methodologies.
• Strong technical writing skills with the ability to produce clear, concise, and accurate validation documentation.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.
• Ability to manage multiple projects simultaneously and meet deadlines.
• Experience with automated systems validation (e.g., PLC, SCADA) is a significant advantage.
• Familiarity with Quality by Design (QbD) principles.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional development, advanced training, and career progression.
• Work on critical validation projects within a reputable pharmaceutical company in Queenstown, Eastern Cape .
• Access to modern facilities and advanced technologies.
• A collaborative and supportive work environment focused on quality and compliance.
• Generous annual leave and company holidays.
• Performance bonus potential.
• Employee wellness and assistance programs.
• Relocation assistance may be considered for qualified candidates.