The Lab Validation Engineer, within our clients bio-pharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging, is responsible for ensuring that manufacturing processes, equipment, and products comply with quality standards and regulatory requirements.
The role supports production and engineering teams by implementing quality control procedures, investigating deviations, and driving continuous improvement in a GMP-regulated environment.
Core Duties and Responsibilities:
Perform quality inspections and testing of manufacturing processes and finished products.
Ensure compliance with GMP and regulatory standards for biopharmaceutical manufacturing.
Investigate deviations, non-conformances, and CAPA activities.
Review and approve quality documentation, validation protocols, and reports.
Support equipment and process qualification activities.
Work cross-functionally with manufacturing, engineering, and validation teams.
Monitor quality metrics and implement continuous improvement initiatives.
Participate in internal audits and regulatory inspections.
Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
Maintain accurate records within quality management systems and document control systems.
Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
Minimum Qualifications and Experience:
Bachelor’s degree in Science, engineering or a related discipline.
2+ years experience in a pharmaceutical, biotech, or GMP manufacturing environment.
Knowledge of GMP regulations and quality systems.
Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.
Strong analytical and problem-solving skills.
Excellent communication and technical report writing.
Ability to work cross-functionally in a highly regulated manufacturing environment.
Strong attention to detail and organisational ability.
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