Manufacturing Technicians in a biotech company operate and maintain specialized equipment to ensure the precise production of biological products. They perform quality control tests, monitor manufacturing processes, and adhere to strict regulatory standards to guarantee product safety and efficacy. Their role is crucial in supporting the scalable and efficient production of biopharmaceuticals.
Operate and monitor bioprocessing equipment
Efficiently operate and monitor bioprocessing equipment to ensure optimal performance and adherence to safety and quality standards. Maintain accurate records of process parameters, troubleshoot equipment issues promptly, and collaborate with cross-functional teams to improve bioprocess workflows. Proven experience in bioprocess technology and attention to detail are essential for successful operation and monitoring.
Perform routine maintenance and calibration
Perform routine maintenance and calibration to ensure equipment operates at peak efficiency and accuracy. Regularly inspect, clean, and adjust devices following manufacturer guidelines and industry standards. Proactively identify potential issues and implement corrective measures to minimize downtime and maintain operational reliability.
Prepare media, buffers, and reagents
Efficiently prepare media, buffers, and reagents by accurately measuring and mixing chemical components according to standardized protocols. Maintain meticulous records of preparation processes to ensure reproducibility and compliance with quality control standards. Ensure all solutions are correctly labeled, stored under appropriate conditions, and regularly checked for contamination or degradation.
Execute batch records and document results
Execute batch records with accuracy and attention to detail, ensuring all production steps are followed according to standard operating procedures (SOPs). Document results promptly and clearly, maintaining compliance with regulatory requirements and quality standards. Suggest improvements in documentation processes to enhance efficiency and traceability in manufacturing operations.
Perform in-process sampling and quality checks
Conduct precise in-process sampling and rigorous quality checks to ensure compliance with production standards and minimize defects. Utilize statistical methods to analyze sample data and identify trends that support continuous process improvement. Suggest corrective actions promptly to maintain product integrity and optimize manufacturing efficiency.
Maintain cleanroom and controlled environments
Maintain strict cleanliness standards in cleanroom and controlled environments by performing regular sanitation, monitoring air quality, and ensuring contamination control protocols are followed. Operate specialized equipment and conduct routine inspections to uphold compliance with industry regulations such as ISO 14644 and GMP. Suggest implementing continuous training programs for staff to enhance adherence to cleanliness procedures and improve overall product quality.
Troubleshoot equipment and process deviations
Troubleshoot equipment and process deviations by analyzing operational data and identifying root causes of malfunctions to ensure optimal performance. Utilize diagnostic tools and maintenance protocols to resolve issues promptly, minimizing downtime and enhancing productivity. Develop and implement corrective actions in collaboration with cross-functional teams to maintain equipment reliability and process consistency.
Adhere to GMP and safety protocols
Strict adherence to Good Manufacturing Practices (GMP) and established safety protocols ensures product quality and workplace safety, minimizing risks and regulatory non-compliance. Candidates must consistently follow standard operating procedures and report any deviations immediately to maintain a safe production environment. Continuous training and vigilance are essential to uphold these standards and support operational excellence.
Assist in validation and process improvement
Support the validation of workflows and protocols to ensure accuracy and compliance with industry standards. Analyze existing processes to identify inefficiencies and recommend targeted improvements for enhanced operational performance. Collaborate with cross-functional teams to implement process improvement initiatives that drive quality and productivity gains.
Collaborate with cross-functional teams
Work closely with cross-functional teams including marketing, product development, and sales to drive project success and ensure alignment of goals. Facilitate effective communication and coordination among departments to optimize workflow and meet deadlines. Develop a collaborative environment that fosters innovation and problem-solving to achieve business objectives efficiently. Cross-functional collaboration is essential for seamless project execution and organizational growth.