Senior Pharmaceutical Validation Engineer - On-Site Paarl

Placements24

Stellenbosch

On-site

ZAR 900,000 - 1,500,000

Full time

13 days ago

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Benefits offered by this job

Competitive salary
Medical aid
Provident Fund
Professional development
Paid time off
Wellness programs

Job summary

Placements24 is assisting a leading pharmaceutical manufacturer in Paarl, Western Cape, seeking a Senior Pharmaceutical Validation Engineer to ensure all manufacturing processes, equipment, facilities and utilities meet regulatory standards through rigorous validation. You will lead validation projects, develop master plans, and deliver compliant validation documentation on site.

The ideal candidate has a chemical/mechanical/electrical engineering background with 6+ years in pharma validation,

Qualifications

  • Bachelor's degree in chemical/ mechanical/ electrical engineering or related science.
  • Minimum 6 years in pharmaceutical validation.
  • Proven IQ/OQ/PQ, Process Validation, Cleaning Validation, and CSV experience.
  • Strong knowledge of cGMP and regulators (FDA/EMA/SAHPRA).
  • Excellent technical writing and attention to detail.
  • Ability to lead validation projects and work cross-functionally.

Responsibilities

  • Develop, execute, and document validation protocols for manufacturing equipment, processes, cleaning, analytical methods, and facilities.
  • Lead validation activities for new equipment installations, process changes, and site expansions.
  • Ensure validation activities comply with cGMP and regulatory guidelines (FDA, EMA, SAHPRA).
  • Prepare validation master plans (VMPs) and annual revalidation plans.
  • Conduct impact assessments and risk analyses related to validation activities.
  • Investigate deviations, out-of-specification results, and equipment failures during validation.

Skills

Validation expertise
IQ/OQ/PQ
CSV
cGMP knowledge
Documentation
Project management
Cross-functional collaboration
GAMP 5 familiarity

Education

Bachelor's degree in Chemical/Mechanical/Electrical Engineering or related science

Job description

Placements24 is assisting a leading pharmaceutical manufacturer in Paarl, Western Cape, seeking a Senior Pharmaceutical Validation Engineer to ensure all manufacturing processes, equipment, facilities and utilities meet regulatory standards through rigorous validation. You will lead validation projects, develop master plans, and deliver compliant validation documentation on site.

The ideal candidate has a chemical/mechanical/electrical engineering background with 6+ years in pharma validation,

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