Validation Services Laboratory Specialist

About the Role

The Validation Services Laboratory Specialist will perform pharmaceutical and biopharmaceutical analytical tests according to validated protocols and GLP procedures. The role includes interpreting results, completing and reviewing laboratory data, and supporting qualification, validation, and analytical activities for various biologics-related studies.

What You'll Do

• Supported Sterile Filter Validation, Extractables & Leachables (E&L) testing, and analytical method development.

• Analyzed data from analytical instruments including HPLC, GC-MS, and ICP-MS.

• Managed the full lifecycle of Validation and Qualification activities.

• Prepared and reviewed SOPs, validation protocols, test plans, and technical reports.

• Communicated technical information with customers and global cross-functional teams.

• Performed testing related to chromatography-based purification processes.

• Conducted Cell-based Assays and qPCR-based analyses.

• Planned, executed, and evaluated analytical method validation studies.

• Prepared and maintained GLP-compliant SOPs, study protocols, and reports.

• Supported GLP inspections and quality system compliance activities.

• Collaborated with customers and global teams through technical discussions and project communications.

• What We're Looking For

• Master’s degree or higher in Life Sciences, Microbiology, Biotechnology, Chemistry, Analytical Chemistry, or a related field.

• Entry-level candidates or candidates with up to 5 years of relevant experience.

• Understanding of GLP (Good Laboratory Practice) environments.

• Ability to understand technical documentation and communicate effectively in English.

• Nice to Have

• Experience in pharmaceutical purification processes or QC analysis.

• Understanding of GLP or other regulatory-based testing and quality environments.

• Experience in writing SOPs and laboratory documentation.

• Experience with Method Validation and Method Transfer.

• Experience with Extractables & Leachables (E&L) studies.

• Experience in non-targeted analysis using HPLC, GC-MS, and ICP-MS.

• Understanding of Toxicological Risk Assessment.

• Experience in analytical method development and new instrument setup/qualification.

• Experience with Mammalian Cell Culture and Virus Handling.

• Understanding of downstream purification processes.

• Experience operating ÄKTA chromatography systems and related equipment.

• Compensation & Benefits

• Salary not disclosed in the posting.