GMP Compliance Specialist

About the job

We are seeking an Engineering Compliance Specialist to support engineering system checks and compliance activities within a GMP-regulated manufacturing environment. The role involves reviewing asset, maintenance, and calibration records, supporting risk assessments, and ensuring engineering activities meet GMP, GDP, and site quality requirements.

Your missions

• Support engineering system checks within a GMP manufacturing environment
• Review asset records and equipment status to ensure proper documentation and compliance
• Conduct or support maintenance risk assessments for manufacturing and engineering systems
• Review calibration status, calibration records, and related documentation
• Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
• Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
• Review and support preparation of GMP documentation, reports, checklists, and compliance records
• Identify documentation gaps and support follow-up actions or remediation activities
• Ensure all work is performed in line with GMP, GDP, and site quality requirements

Your profile

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5-7 years of experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments.
• Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities.
• Good understanding of GMP documentation practices and engineering compliance requirements.
• Ability to review engineering records, maintenance records, calibration documentation, and related technical documents.
• Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders.
• Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage.
• Exposure to validation, qualification, CQV, or GMP project support activities is preferred.
• Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage.
• Experience supporting audit readiness or GMP documentation remediation activities is preferred.
• Fluent in English, both written and spoken.

What we offer

• 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 (afterworks, 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.