GMP Equipment Qualification Engineer

About the job

We are seeking a Qualification Engineer to support equipment qualification activities in a GMP-regulated manufacturing environment. The role involves executing IQ, OQ, and PQ activities, preparing and reviewing GMP qualification documents, and collaborating with cross-functional teams including Engineering, Manufacturing, Quality, and Validation.

• Support qualification activities for manufacturing equipment used in GMP production.
• Execute and document IQ, OQ, and PQ activities.
• Prepare and review qualification protocols, test scripts, reports, and other GMP documents.
• Work closely with Engineering, Manufacturing, Quality, Validation, and Maintenance teams.
• Support equipment readiness checks, risk assessments, deviation handling, and qualification strategy discussions.
• Ensure all qualification work follows GMP, GDP, and data integrity requirements.
• Review and support approval of documents related to the equipment qualification and validation lifecycle.
• Good to have:
  Experience with pharmaceutical or biotech processing equipment such as bioreactors, chromatography systems, ultrafiltration/filtration systems, hold tanks, vessels, or other GMP manufacturing equipment.

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline.
• Minimum2–3 years of experiencein manufacturing equipment qualification within pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments.
• Hands-on experience with equipment qualification activities, including IQ, OQ, PQ, validation documentation, and qualification lifecycle management.
• Good understanding of GMP, GDP, deviation management, change control, and data integrity principles.
• Ability to independently review, execute, and manage qualification protocols and related documentation.
• Strong communication and stakeholder management skills, with the ability to collaborate across cross-functional teams.
• Experience in CQV projects, technology transfer, or new facility/equipment setup will be an added advantage.
• Exposure to biologics, sterile manufacturing, API, or vaccine manufacturing environments is preferred.
• Experience supporting audits, inspections, or regulatory readiness activities is an advantage.
• Fluent in English, both written and spoken.

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (after works, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.