GMP Engineering Compliance Specialist (Life Sciences)

TL;DR

GMP Engineering Compliance Specialist (Life Sciences): Supporting engineering system checks and compliance activities within GMP-regulated manufacturing environments with an accent on asset records, maintenance risk assessments, and calibration records. Focus on ensuring engineering activities meet GMP/GDP requirements, identifying documentation gaps, and maintaining audit readiness.

Company

Independent technology consulting firm providing solutions across Information Systems, Telecom, Life Sciences, and Engineering.

What you will do

• Support engineering system checks within GMP manufacturing environments.
• Review asset records and equipment status to ensure proper documentation and compliance.
• Conduct maintenance risk assessments for manufacturing and engineering systems.
• Review calibration status, records, and related documentation.
• Identify documentation gaps and support follow-up remediation activities.
• Collaborate with Engineering, Quality, Maintenance, Validation, and Manufacturing teams.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Experience in pharmaceutical, biotech, or GMP-regulated manufacturing environments.
• Hands-on experience in engineering system checks, asset review, or calibration activities.
• Strong understanding of GMP documentation practices and compliance requirements.
• Fluent in English, both written and spoken.

Nice to have

• Experience in biologics, sterile manufacturing, or API production.
• Exposure to validation, qualification, CQV, or GMP project support.
• Familiarity with equipment lifecycle management or asset management systems.
• Experience supporting audit readiness or GMP documentation remediation.

Culture & Benefits

• International community with over 110 nationalities.
• Robust training system via internal Academy with 250+ modules.
• Strong internal growth opportunities and trust-based leadership culture.
• Commitment to ESG and sustainability through the WeCare Together program.
• Vibrant workplace with regular internal events and team buildings.

Hiring process

• Brief introductory virtual or phone call to discuss motivations.
• Average of 3 interviews with line managers and team members.
• Case study or technical assessment depending on the position.