Responsibilities
· Lead and execute equipment and process validation activities, including DQ, IQ, OQ, and PQ.
· Develop, review, and maintain validation protocols and reports, ensuring full compliance with applicable regulatory and quality requirements.
· Plan and manage preventive and corrective maintenance programs for production equipment, cleanroom systems, utilities, and facility infrastructure.
· Ensure high equipment availability and reliability, with strict adherence to calibration and maintenance schedules.
· Troubleshoot and resolve equipment and system issues in a timely manner, ensuring operations remain within defined specifications and regulatory requirements.
· Drive continuous improvement initiatives to enhance equipment performance, process efficiency, reliability, and overall uptime.
· Prepare and maintain engineering documentation, including SOPs, work instructions, and maintenance records, ensuring compliance with document control and data integrity requirements.
Requirements
· Bachelor’s degree or higher in Biomedical Engineering, Life Sciences, Chemical Engineering, or a related discipline.
· Minimum 5 years of relevant experience in the medical device, pharmaceutical, or other highly regulated manufacturing environments.
· Hands-on experience in equipment and process validation, as well as equipment and facility maintenance.
· Experience with process water systems, solution mixing and preparation systems, and cleanroom utilities (including HVAC) is an added advantage.
· Strong analytical and problem-solving capabilities, with the ability to work both independently and collaboratively within cross-functional teams.
· Demonstrated sense of ownership and accountability, with the ability to manage multiple priorities effectively in a fast-paced project environment.