Validation Chemist

The Opportunity

We are seeking a Validation Chemist to join our Quality team, with a primary focus on cleaning and analytical validation support for validation programs. In this role, you will develop, validate, and execute analytical methods that support cleaning validation, equipment qualification, new product development, quality control, and regulatory compliance. You will play a key role in ensuring manufacturing equipment and processes meet regulatory requirements through scientifically sound validation strategies and residue testing programs.

Working closely with Quality, Operations, Manufacturing, and R&D teams, you will support cleaning validation protocols, establish analytical testing methods for residue detection, execute validation studies, and drive continuous improvement initiatives while maintaining the highest standards of product quality and compliance.

What You'll Do

• Lead and support cleaning validation activities, including protocol development, execution, data analysis, reporting, and ongoing program maintenance.
• Develop, verify, and validate analytical methods used for cleaning validation residue testing and product analysis.
• Establish scientifically justified cleaning limits and acceptance criteria in accordance with regulatory expectations and company standards.
• Collaborate with Manufacturing and Quality teams to assess cleaning processes, identify risks, and implement improvements.
• 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, cleaning validation investigations, and product-related testing challenges.
• Validate laboratory and manufacturing equipment, including protocol development, execution, reporting, and ongoing performance monitoring.
• Prepare accurate validation 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, investigations, and corrective actions.
• Support change control processes, including impact assessments and implementation activities.
• Maintain documentation required for quality systems, regulatory inspections, 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.

What You'll Bring

Education & Experience

• Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 2 years of experience using analytical instrumentation such as HPLC, LC-MS, ICP, or similar technologies.
• Minimum 2 years of validation experience in a GMP-regulated environment.
• Experience developing, executing, or supporting cleaning validation programs is strongly preferred.
• Experience performing residue testing, recovery studies, swab validation, rinse sampling, or cleaning verification activities is considered a strong asset.
• Experience working in a GMP-regulated pharmaceutical, nutraceutical, or related manufacturing environment.
• Experience with solid dosage forms is considered an asset.

Technical Skills

• Strong understanding of analytical chemistry principles and laboratory practices.
• Working knowledge of cleaning validation principles, including residue limit calculations, recovery studies, risk assessments, and sampling methodologies.
• Experience with chromatography data systems and analytical software.
• Familiarity with Thermo Chromeleon™ CDS is preferred.
• Proficiency with Microsoft Office applications and Laboratory Information Management Systems (LIMS).
• Knowledge of validation requirements and regulatory guidance, including:
• • 21 CFR Part 11
  • Annex 15 (EudraLex)
  • PIC/S GMP Guidance
  • Cleaning Validation Guidance Documents
  • GAMP Guidelines
  • Relevant GMP requirements