We are seeking a skilled Validation Engineer with expertise in single-use technology (SUT) to support validation activities related to bioreactors, mixing systems, and other disposable process equipment used in biopharmaceutical manufacturing. The successful candidate will be responsible for the development and execution of validation protocols (IQ/OQ/PQ), ensuring compliance with GMP, FDA, EMA, and industry standards. This role is critical in ensuring the reliability, efficiency, and regulatory compliance of bioprocessing equipment.

Key responsibilities:

• Develop, execute, and document validation protocols (IQ, OQ, PQ) for single-use bioreactors, mixing systems, and other process equipment.
• Ensure compliance with GMP, FDA, EMA, ISO, and industry standards related to single-use technology.
• Perform risk assessments and gap analyses for single-use components to ensure process integrity.
• Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Process Development, and Regulatory Affairs, to support validation efforts.
• Investigate and resolve validation deviations, anomalies, and non-conformances.
• Author and review Standard Operating Procedures (SOPs), User Requirement Specifications (URS), and Validation Master Plans (VMPs).
• Lead and participate in FAT, SAT, and commissioning of single-use systems.
• Conduct performance qualification studies, including sterility, extractables & leachables testing, and integrity testing.
• Stay updated with industry trends, technological advancements, and regulatory changes affecting single-use technologies.
• Provide training and technical support on validation processes to internal stakeholders.

Qualifications:

• Bachelor’s or Master’s degree in Engineering, Biotechnology, Biochemistry, or a related field.
• 5+ years of validation experience in the biopharmaceutical or medical device industry.
• Hands-on experience with single-use bioreactors, mixing systems, and filtration assemblies.
• Strong knowledge of GMP, FDA 21 CFR Part 11, ISO 13485, USP, and ICH guidelines.
• Experience with risk-based validation approaches and industry best practices.
• Familiarity with data integrity principles, electronic validation systems, and automation is a plus.

Please get in touch if you are interested in applying!