Method & Process Validation Specialist

Method & Process Validation Specialist

Lonza

Geleen, Netherlands

Key responsibilities:

• Review and approve documentation related to the qualification, validation, and verification of QC analytical methods.
• Quality oversight of validation of manufacturing, cleaning, disinfection, and shipping processes.
• Offer validation knowledge support for projects to guarantee compliant analytical, manufacturing, and shipping processes.
• Ensure that deviations and change records are well detailed, and applicable corrective actions and systemic solutions are applied.
• Comply strictly with Good Manufacturing Practices (GMP) guidelines in all activities.
• Collaborate with teams to successfully implement quality management and GxP regulations.

Key requirements:

• A bachelors degree in biotechnology or a related field.
• Over 5 years of experience in preferably MSAT, QC QA, or PD with a strong lab background in testing.
• Proven expertise in validation and report authoring.
• Excellent problem-solving skills with the ability to communicate effectively and make fast-paced decisions.
• In-depth knowledge of GMP, quality management, European and FDA regulations, cGMP, and GDP.
• Strong knowledge of validation methodologies and manufacturing processes.
• Outstanding analytical skills with a detailed approach to problem-solving.
• Ability to work autonomously with sound industry knowledge and project proficiency.