Lyophilization Technician I

Curia · Albuquerque

Job Title: Lyophilization Technician I (Overnight)
Department: Engineering
Reports To: Associate Director of Engineering
FLSA Status: Non-Exempt

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

Qualifications

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

Supervisory Responsibilities

This role does not have supervisory responsibilities.

Competencies

Execution & Reliability: Consistently follows procedures and delivers high-quality work in a regulated environment
Accountability: Takes ownership of assigned operations and understands when to escalate issues
Attention to Detail: Maintains accuracy in documentation and process monitoring
Problem Solving: Applies basic troubleshooting skills and seeks support when appropriate
Collaboration & Communication: Effectively communicates with cross-functional teams and across shifts

Language Skills

Ability to read and interpret documents such as safety instructions, standard operating procedures, policies, batch records, and manuals. Ability to write clearly and communicate effectively.

Mathematical Skills

Ability to add, subtract, multiply, and divide using whole numbers, common fractions, decimals, and percentages. Ability to draw and interpret bar graphs.

Reasoning Ability

Ability to demonstrate understanding and effective application of written and oral instructions.

Computer Skills

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to support manufacturing operations. Essential skills include proficiency in manufacturing software and Microsoft Office applications including Word, Excel, Outlook, and PowerPoint.

Other Skills and Abilities

Fosters a collaborative and positive work environment
Champions change
Promotes a safe and healthy work environment by actively identifying and addressing potential hazards and following established safety protocols
Demonstrates strong attention to detail
Skilled in producing comprehensive and detailed documentation
Ability to work at elevated heights

Other Qualifications

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

Physical Demands

Frequent bending, reaching, stooping, kneeling, climbing, and standing for extended periods
Ability to lift, maneuver, and install lyophilizer spacer bars and associated equipment components
Ability to lift and carry materials and equipment up to 50 pounds
Required to perform physical inspections of lyophilizers and associated manufacturing equipment
Ability to climb vertical ladders and work safely at elevated heights
Ability to work in confined manufacturing and cleanroom environments
Exposure to extreme piping temperature conditions, including temperatures up to 127°C and as low as -80°C
Required to work around steam, pressure systems, vacuum systems, and industrial manufacturing equipment
Ability to wear required PPE, including full cleanroom gowning and respiratory protection, for extended periods
Ability to perform repetitive motions associated with manufacturing operations and equipment setup
Ability to work extended shifts in both cleanroom and control room environments
Visual acuity sufficient to monitor equipment status, alarms, batch records, gauges, and process data
Must be physically capable of responding to manufacturing issues and operational needs throughout the facility

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.

The Lyophilization Technician I is responsible for executing routine manufacturing operations in support of sterile drug product production within a cGMP-regulated environment. This role supports the operation, monitoring, and documentation of lyophilization (freeze-drying) processes while ensuring adherence to validated process parameters and regulatory requirements.

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