Equipment Qualification Engineer (Biotech)

TL;DR

Equipment Qualification Engineer (Biotech): Supporting equipment qualification activities in a GMP-regulated manufacturing environment with an accent on executing IQ, OQ, and PQ protocols. Focus on preparing GMP documentation, managing qualification lifecycles, and collaborating with cross-functional teams to ensure compliance with data integrity and quality standards.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions across Information Systems, Telecom, Life Sciences, and Engineering to over 1000 clients globally.

What you will do

• Execute and document IQ, OQ, and PQ activities for manufacturing equipment.
• Prepare and review qualification protocols, test scripts, and reports in compliance with GMP.
• Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
• Support equipment readiness checks, risk assessments, and deviation handling.
• Ensure all work adheres to GMP, GDP, and data integrity requirements.
• Review and support approval of documentation related to the equipment qualification lifecycle.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or Biotechnology.
• 2–3 years of experience in manufacturing equipment qualification within GMP-regulated environments.
• Hands-on experience with IQ, OQ, PQ, and validation documentation.
• Strong understanding of GMP, GDP, deviation management, and change control.
• Fluent in English, both written and spoken.

Nice to have

• Experience with pharmaceutical or biotech processing equipment like bioreactors or chromatography systems.
• Background in CQV projects, technology transfer, or new facility setup.
• Exposure to biologics, sterile manufacturing, or vaccine production.
• Experience supporting audits and regulatory inspections.

Culture & Benefits

• International community with 110+ nationalities.
• Robust training system with internal Academy and 250+ modules.
• Commitment to sustainability and ESG through the WeCare Together program.
• Vibrant workplace with frequent team events and afterworks.
• Equal-opportunity employer focused on diversity and inclusion.

Hiring process

• Brief virtual or phone conversation to discuss motivations.
• Approximately 3 interviews with the line manager and team members.
• Potential case study, technical assessment, or problem-solving scenario.