Validation Chemist

We are seeking a Validation Chemist to join our Quality team. In this role, you will develop, verify, validate, and transfer analytical methods that support new product development, quality control, and regulatory compliance. You will play a key role in bringing analytical testing in-house, implementing modern technologies, and ensuring testing methods deliver accurate, reliable results. Working closely with cross-functional teams, you will support method development, equipment qualification, troubleshooting, and continuous improvement initiatives while helping reduce our environmental footprint through innovative laboratory practices.

Responsibilities

Develop, verify, and validate analytical methods for new and existing products; Support method development for product testing, stability studies, and routine quality control analysis; Create training materials and facilitate method transfers to the Quality Control team; Manage multiple validation projects simultaneously while meeting timelines and business priorities; Troubleshoot analytical methods, instrumentation, and product-related testing challenges; Validate new laboratory equipment, including protocol development, execution, reporting, and ongoing performance monitoring; Prepare accurate analytical reports and maintain data integrity using approved procedures, SOPs, LIMS, and cGMP requirements; Collaborate with Quality, R&D, Operations, and other departments to execute validation activities and corrective actions; Support change control processes, including impact assessments and implementation activities; Maintain documentation required for quality systems and SR&ED submissions; Ensure compliance with all safety, quality, and regulatory requirements; Travel to other company sites for training or project support as needed

Requirements

Bachelor of Science in Analytical Chemistry or a related scientific discipline; Minimum 2 years of experience using analytical instrumentation such as HPLC, LC-MS, ICP, or similar technologies; Minimum 1 year of method validation experience; Experience working in a GMP-regulated pharmaceutical, nutraceutical, or related manufacturing environment; Strong understanding of analytical chemistry principles and laboratory practices; Experience with chromatography data systems and analytical software; Proficiency with Microsoft Office applications and Laboratory Information Management Systems (LIMS); Knowledge of software and equipment validation requirements, including 21 CFR Part 11, Annex 15 (EudraLex), GAMP Guidelines, and relevant GMP requirements; Strong analytical thinking and problem-solving skills; Excellent written, verbal, and presentation communication skills; Ability to work independently and collaboratively within a team environment; Strong organizational skills and the ability to manage multiple priorities; Effective relationship-building skills and a collaborative mindset

Nice to have

Experience with solid dosage forms is considered an asset; Familiarity with Thermo Chromeleon CDS is preferred