Engineer I - Engineering, Validation
Core
Support quality assurance and validation activities to ensure compliance with regulatory and internal quality standards in biologics manufacturing.
Role type
Validation Engineer I
Builds
Validated equipment, utilities, and systems for drug substance biomanufacturing
Domain
Biopharmaceutical manufacturing / GMP compliance
Required skills
cGMP regulations, validation standards (ISPE, ASTM), equipment commissioning and qualification, validation protocol drafting and review, change control assessment, deviation investigation, risk assessment, Validation Master Plan maintenance
Preferred skills
aseptic processing, cell culture, protein purification, process validation, 21 CFR Part 11 compliance, computerized system validation, continuous improvement, quality risk management
Technologies
Single-use systems, GPEx® technology, flexible manufacturing systems
Responsibilities
Review and approve validation documents, support commissioning and qualification of equipment and utilities, lead validation activities for new equipment and systems, serve as QA subject matter expert for Validation and Risk Management, assess change controls for impact to validated systems, support audits and regulatory inspections, investigate deviations related to validation activities, maintain Validation Master Plan, manage validation contractors, provide training and technical support
Seniority
Mid-level, hands-on IC