Pharmaceutical Validation Engineer

Placements24

Queenstown

On-site

NZD 90,000 - 130,000

Full time

2 days ago
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Benefits offered by this job

Competitive salary
Career development opportunities

Job summary

Placements24 is seeking a meticulous Pharmaceutical Validation Engineer to ensure GMP-compliant validation of equipment, processes, and facilities in Queenstown. You will develop, execute, and document validation plans and stay aligned with regulatory expectations.

The role requires a engineering degree and a minimum of four years in pharma validation, with strong technical writing and organizational skills for managing multiple projects.

Qualifications

  • Bachelor's degree in Engineering or related field.
  • Minimum 4 years of validation experience in pharma/biopharma.
  • Strong understanding of validation principles, lifecycle, and GMP.
  • Experience with pharmaceutical equipment and processes.
  • Excellent technical writing, communication, and organizational skills.
  • Ability to manage multiple validation projects simultaneously in Queenstown.

Responsibilities

  • Develop, execute, and document validation protocols for equipment IQ/OQ/PQ.
  • Prepare validation summary reports, deviations, and change controls.
  • Ensure activities comply with GMP, regulatory guidelines, and SOPs.
  • Collaborate with cross functional teams to define validation needs.
  • Maintain audit-ready validation documentation.
  • Support regulatory inspections and internal audits.

Skills

Technical writing
Communication
Organizational skills

Education

Bachelor's degree in Engineering or related field

Job description

About the Role

Our client is seeking a meticulous and experienced Pharmaceutical Validation Engineer to ensure the compliance and reliability of manufacturing equipment, processes, and facilities in Queenstown . This crucial role involves developing, executing, and documenting validation protocols that meet stringent regulatory requirements, including GMP. You will work closely with engineering, production, and quality assurance teams to confirm that all systems perform as intended and are suitable for their intended use. The ideal candidate will possess a strong understanding of validation principles, excellent technical writing skills, and a commitment to maintaining the highest standards of pharmaceutical quality and safety.

Key Responsibilities
  • Develop, execute, and document validation protocols for equipment (IQ/OQ/PQ), processes, cleaning, and utilities.
  • Ensure all validation activities comply with Good Manufacturing Practices (GMP) , regulatory guidelines (e.g., FDA, SAHPRA), and internal SOPs.
  • Prepare validation summary reports, deviations, and change control documents related to validation activities.
  • Collaborate with cross-functional teams to define validation requirements and ensure timely completion of validation projects.
  • Maintain validation documentation in an organized and audit-ready state.
  • Participate in regulatory inspections and internal audits, providing support and documentation as needed.
  • Stay current with industry best practices and regulatory expectations for pharmaceutical validation.
Requirements
  • Bachelor's degree in Engineering (Mechanical, Chemical, Electrical) or a related scientific field.
  • Minimum of 4 years of experience in validation within the pharmaceutical or biopharmaceutical industry.
  • Thorough understanding of validation principles, lifecycle management, and regulatory expectations (GMP, GAMP ).
  • Experience with various types of pharmaceutical equipment and processes.
  • Excellent technical writing, communication, and organizational skills.
  • Ability to manage multiple validation projects simultaneously in a demanding environment in Queenstown .
Benefits
  • Competitive salary and comprehensive benefits package.
  • Opportunities for professional development and career advancement.
  • Work in a facility equipped with modern pharmaceutical manufacturing technology.
  • A supportive team environment focused on ensuring product quality and compliance.
  • Contribute to the reliable supply of safe and effective pharmaceutical products.
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