Lyophilization Technician I

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.