About the role
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.
What You Will Achieve
In this role, you will:
• Support the planning and execution of analytical method validation activities for chemical and physicochemical methods in accordance with approved protocols.
• Prepare and organize samples, standards, reagents, solutions, reference materials, and documentation required for validation studies.
• Execute validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, detection limit, quantitation limit, and method equivalency, as applicable.
• Ensure training records reflect current qualification to perform validation, verification, and routine analytical method activities.
• Verify instrument readiness, calibration status, analytical conditions, and system suitability requirements before executing validation or verification testing.
• Evaluate validation data for compliance with predefined acceptance criteria, including statistical assessment, trend evaluation, and investigation of atypical or out-of-specification results.
• Ensure validation documentation, raw data, calculations, protocols, reports, and quality records comply with Good Manufacturing Practices, Good Laboratory Practices, data integrity expectations, and applicable procedures.
• Document and report validation results in computerized systems, perform data entry and review, support approval workflows, and maintain inspection-ready records.
• Support investigations, deviations, change controls, method transfers, and continuous improvement initiatives related to analytical method lifecycle management.
Here Is What You Need (Minimum Requirements)
• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline with relevant experience in a GMP-regulated laboratory with 4 years of relevant experience.
• Demonstrated experience supporting or executing analytical method validation, verification, transfer, or lifecycle activities for chemical or physicochemical methods.
• Ability to interpret analytical methods, validation and verification protocols, compendial procedures, Standard Operating Procedures, technical procedures, and applicable regulatory expectations.
• Working knowledge of Good Manufacturing Practices, Good Laboratory Practices, data integrity principles, laboratory documentation requirements, and quality systems applicable to analytical testing.
• Ability to organize validation and verification activities, manage multiple priorities, follow approved timelines, and maintain complete, accurate, and inspection-ready records.
• Strong written and verbal communication skills to document technical results, summarize conclusions, support investigations, and communicate method-related issues to cross-functional stakeholders.
• Proficiency with analytical laboratory instruments and computerized systems used for method validation and verification, including appropriate instrument checks, system suitability evaluation, data entry, review, and interpretation.
• Intermediate English level, for reading and drafting technical documents
Bonus Points If You Have (Preferred Requirements)
• Hands-on experience executing or supportin
Apply on employer site ↗