Divasakar
About Candidate
Dedicated Bioprocess Engineer with experience in biopharmaceutical equipment validation,
process optimization, and compliance assurance. Skilled in equipment qualification (IQ, OQ,
PQ), GMP standards, troubleshooting biopharma manufacturing processes, with technical
documentation and troubleshooting expertise, collaborate effectively with cross-functional
teams ensures efficient and reliable manufacturing operations.
Looking for opportunities in life sciences consulting or biopharma manufacturing that allow
me to expand my expertise and contribute meaningfully, while maintaining a sustainable
work-life balance.
Location
Education
Work & Experience
• Execute IQ/OQ/PQ protocols for new and existing systems, ensuring optimal performance. • Collaborate with cross-functional teams, including QA, production and Automation to streamline validation workflows.
• Lead validation and qualification activities for biopharmaceutical equipment, ensuring compliance with global regulatory standards. • Negotiating and influencing decisions related to validation strategies • Managing client expectations and providing solutions in compliance with GMP and regulatory standards. • Troubleshoot and resolve technical issues related to bioprocessing equipment and automation systems. • Executed Functional Design Specifications (FDS) for automation systems and process control enhancements. • Assisted in process optimization initiatives to improve efficiency and reduce operational risks. • Maintain detailed technical documentation, qualification protocols, and compliance reports.
