Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
Minimum of 7 years in analytical development or validation in Pharmaceutical/Biopharmaceutical environments, or an advanced degree.
Familiarity with KNEAT Program is a plus.
Experience in reviewing and approving Life Cycle Validation Documents.
Proficiency in commissioning and qualification protocols for equipment and utilities in Biopharmaceutical settings.
Expertise in Computer System Validation, including SCADA and MES.
Experience with QC/Micro Laboratory Instrument Qualification and method validation.
Responsibilities
Drive the validation and transfer of analytical laboratory methods.
Support the execution, issue resolution, and approval of test plans or protocols.
Troubleshoot analytical methods and equipment.
Ensure laboratory equipment is maintained and compliant with regulatory standards.
Generate protocols, reports, and other technical documents, including raw material qualifications.
Apply scientific principles and statistics to problem-solving and recommendations.
Assist in the installation, qualification, and maintenance of AQC instrumentation.
Benefits
Opportunity to work in a dynamic and innovative laboratory environment.
Involvement in projects aligned with regulatory compliance and quality standards.
Access to continuous training and development opportunities.
Collaborative work culture that encourages knowledge sharing.
Exposure to cutting-edge technologies in the biopharmaceutical field.
Full Job Description
Responsibilities:
Drive analytical method validation/ transfer of laboratory methodologies.
Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.
Support troubleshooting of analytical methods.
Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.
Use sound scientific principles and statistical techniques to solve problems and make recommendations.
May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
Requirements:
Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
Minimum of 7 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
Nice to have the KNEAT Program, not required.
Experienced in reviewing and approving Life Cycle Validation Documents including:
Familiar with paperless validation software for life science.
Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.
Computer System Validation protocols and reports, including SCADA, MES.
QC/Micro Laboratory Instrument Qualification and method validation.
Skills:
Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.
Knowledge of analytical methods and operations with strong emphasis in problem-solving.
Knowledge about analytical method validation.
Intermediate statistical knowledge and experience with data analysis.
Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods.
Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
