Laboratory Operations Project Engineer
Contracting – Antwerp
Key Responsibilities
Method Validation & Compliance
Perform compliance assessments of method validation and compendial compliance dossiers.
Review validation and method transfer test results to ensure regulatory compliance.
Verify compendial test methods and ensure proper implementation within QC operations.
Validate supporting data files and tools (e.g., SoftMaxPro, Excel).
Project Coordination & Implementation
Coordinate and plan activities for the implementation of new analytical methods and procedures.
Ensure proper documentation and adherence to internal procedures and GMP requirements.
Collaborate with cross-functional teams to ensure timely execution of projects.
Documentation & Reporting
Write and review validation protocols, testing scripts, and technical reports.
Manage and document analytical deviations according to quality procedures.
Support regulatory documentation and may co-author submissions for new medicines or vaccines.
Investigation & Problem Solving
Investigate analytical deviations and laboratory issues efficiently and thoroughly.
Perform root cause analysis using structured methodologies such as DMAIC.
Initiate and follow up corrective and preventive actions (CAPA) to resolve quality-related deficiencies.
Operational Support
Provide technical support to QC analysts during test execution.
Conduct troubleshooting of analytical methods and laboratory equipment issues.
Contribute to continuous improvement initiatives within laboratory operations.
Qualifications
Education
Master’s degree in:
Industrial Engineering, Civil Engineering, or Bio-Engineering
Industrial Pharmacy
Biochemistry, Biotechnology, or a related scientific field
Experience
Several years of relevant experience in a pharmaceutical, biotechnology, or production environment is preferred.
Experience working in a GMP-regulated environment is strongly desired.
Skills & Competencies
Strong technical writing skills for protocols, reports, and validation documentation.
Excellent analytical and problem-solving abilities.
Strong communication skills (written and verbal).
High level of accuracy and organizational ability.
Team player with strong interpersonal skills.
Languages
Fluent Dutch (written and spoken).
Good command of English (written and spoken).