Process Development Technician

• Executes SOPs for unit operations (daily and long term).
• Includes CIP, SIP, and cleaning and sanitization of the facility.
• Operates of buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
• Performs primary troubleshooting in time effective manner and act as a lead investigator SME of product/process deviations.
• Supports implementation of new technology for process execution and/or analysis. Interacts across the asset to achieve production schedule.
• Organizes daily routine when supervisors are not available.
• Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
• Archives various documentation according to established procedures.
• Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
• Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment. Provides support during audits and with audit observation closure.
• Perform skills training and provide subject matter expertise to training materials.
• Maintains a safe working environment.
• Thorough understanding of cGMP requirements and safety practices.
• Employs Automated systems, enterprise systems, and available technology to execute work.
• Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
• Strives for Right first time execution through flawless execution and ownership of the process.
• Purification operational support in a large scale commercial manufacturing environment.
• 2nd shift rotating. The rotation would be 3 days on, 2 days off, 2 days on, 3 days off, 2 days on, 2 days off then it would repeat itself

Top 3 Critical Skills Required:

• Purification
• CIP/SIP experience
• Previous cGMP experience

EDUCATION:

• High School Diploma

EXPERIENCE:

• 0-2 years

All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.
If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!