Quality Specialist Engineer
Core
Provide expert oversight and guidance on investigations, change controls, and compliance activities for maintenance and engineering functions to ensure adherence to GMP standards.
Role type
Quality Specialist Engineer (GMP Compliance)
Builds
Audit-ready performance in maintenance and engineering operations
Domain
Life Sciences / Biotechnology / GMP Manufacturing
Deliverable
client delivery
Required skills
GMP standards knowledge, investigation oversight, change control administration, deviation and failure report assessment, corrective and preventive action support, cross-functional collaboration, safety compliance
Preferred skills
BSc in Biotech, Chemistry, or Engineering, hands-on industry experience, customer-centric approach, process improvement, stakeholder management
Technologies
None stated
Responsibilities
Provide oversight for investigations linked to Maintenance and Engineering activities, ensure strict adherence to GMP standards across operations, review and assess change-control documentation and failure-investigation reports, review key GMP documentation including SOPs, coach and support personnel in GMP-compliance activities, collaborate with cross-functional teams to drive continuous improvement
Seniority
Individual Contributor, specialized role
