Overview In this role you validate and transfer analytical methods, support test plans and troubleshooting, and ensure validated systems and methods meet regulatory expectations. You will work within the AQC/analytical development environment to maintain equipment qualification and generate technical documents. You'll apply statistics and scientific principles to solve problems and support life cycle validation activities. This role offers impact across method validation, transfer, and instrument qualification in a regulated biopharmaceutical or pharmaceutical setting.
Responsibilities- Drive analytical method validation and transfer of laboratory methodologies
- Support execution and resolution of discrepancies in test plans/protocols and obtain completion approval
- Troubleshoot analytical methods and maintain validated state of laboratory equipment
- Ensure methods transferred comply with company and regulatory requirements
- Generate protocols, reports, and other technical documents; support raw material qualification for new products
- Apply sound scientific principles and statistics to problem solving and recommendations
- Support installation/IOQ/maintenance/troubleshooting of instrumentation in the AQC group (as needed)
Key requirements- Bachelor's degree (or equivalent) in biotechnology, Microbiology, Pharmacy, Chemistry or related field
- Minimum 7 years of analytical development or validation experience in pharmaceutical/biopharmaceutical or related manufacturing environment; advanced degree if applicable
- Experience reviewing and approving Life Cycle Validation Documents
- Familiar with paperless validation software for life sciences
- Experience with commissioning, installation, operational and performance qualification protocols/reports for equipment, facilities & utilities
- Knowledge of QC/Micro Laboratory Instrument Qualification and method validation
- Experience with Computer System Validation: SCADA, MES; basic regulatory standards (CGMP, USP, ICH, 21 CFR)
- Strong technical writing skills
- Problem-solving mindset
- Strategic thinking and business orientation
- Analytical method validation
- cGMP knowledge, especially method validation and investigations
- Statistical analysis and data interpretation
