Summary

The Lyophilization Technician I is accountable for overseeing clinical and commercial lyophilization operations at the site, specifically managing the operation of lyophilization equipment and actively participating in production activities related to lyophilization. This position upholds standard operating procedures (SOPs) and adheres to current good manufacturing practices (cGMPs) within the lyophilization department. Responsibilities include completing master batch record (MBR) documentation, aiding in the development and review of SOPs for the department, and ensuring comprehensive quality reporting documentation. This overnight position requires a self-motivated individual capable of working independently while maintaining alignment with site procedures and escalation protocols.

Job description

Position Summary

The Lyophilization Technician I is accountable for overseeing clinical and commercial lyophilization operations at the site, specifically managing the operation of lyophilization equipment and actively participating in production activities related to lyophilization. This position upholds standard operating procedures (SOPs) and adheres to current good manufacturing practices (cGMPs) within the lyophilization department. Responsibilities include completing master batch record (MBR) documentation, aiding in the development and review of SOPs for the department, and ensuring comprehensive quality reporting documentation. This overnight position requires a self-motivated individual capable of working independently while maintaining alignment with site procedures and escalation protocols.

Essential Duties and Responsibilities

Execute lyophilization operations using SERAIL and IMA equipment in accordance with batch records, SOPs, and cGMP requirements
Ensure lyophilizers are cleaned, sterilized, and tested for leaks before manufacturing
Operate lyophilizers according to product specifications, including temperature, pressure, time, and validated cycle parameters
Monitor lyophilization cycles and review process data to ensure adherence to validated cycles and product SOP requirements
Spend extended periods in the control room overseeing lyophilization cycles, data trends, and system alarms
Perform routine in-process checks and ensure accurate, contemporaneous documentation in both paper-based and electronic systems
Support loading and unloading of lyophilizers within classified cleanroom environments, including Grade A (ISO 5) areas
Identify process deviations, perform initial troubleshooting, and escalate issues through established 24/7 management channels
Communicate with production and engineering staff regarding the status of lyophilization operations and assist other shifts as needed
Assist with equipment setup, cleaning, and basic maintenance activities
Comprehend and follow SOPs, cGMPs, safety practices, and good aseptic techniques to produce sterile quality products
Perform aseptic gowning for various classifications of cleanroom areas
Document and review associated paperwork for accuracy and clarity
Work with peers to support training activities as directed by management
Maintain up-to-date training requirements
Maintain compliance with all safety, quality, and regulatory standards
Other duties as assigned

Minimum Requirements

High school diploma or general education degree (GED)
Two (2) years related experience in production, manufacturing, and/or cleanroom preferred
Experience working in a cGMP-regulated environment
Basic understanding of lyophilization processes or similar automated manufacturing systems
Ability to follow detailed procedures and maintain accurate documentation
Demonstrated ability to work independently and manage responsibilities during off-shift operations

Preferred Qualifications

Technical or associate degree preferred
Hands-on experience with SERAIL and/or IMA lyophilizers
Experience in aseptic/sterile manufacturing environments, including Grade A (ISO 5) cleanrooms
Familiarity with automated control systems (e.g., SCADA or equivalent)
EPA certification preferred but not required

Additional Information

Overnight shift: 6:00 PM – 6:30 AM. 24/7 management and escalation support structure in place. May be required to move between shifts based on staffing needs, including vacation and sick time coverage. May be required to work different shifts and extended hours during maintenance shutdown periods.

Requirements

High school diploma or GED
Two years related experience in production, manufacturing, and/or cleanroom preferred
Experience working in a cGMP-regulated environment
Basic understanding of lyophilization processes or similar automated manufacturing systems
Ability to follow detailed procedures and maintain accurate documentation
Demonstrated ability to work independently and manage responsibilities during off-shift operations
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Must be able to obtain and maintain gowning certification
Must be able to wear a respirator

Company overview

Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.