Purification Lab Technician; Night Shift

Position: Purification Lab Technician (Night Shift)
Job Title:

Purification Lab Technician (Night Shift)

Job Description

The Purification Lab Technician (Night Shift) supports large-scale biopharmaceutical manufacturing by performing purification, cleaning, and production operations in a regulated GMP cleanroom environment. This role focuses on operating purification equipment, preparing and handling buffers and chemicals, completing accurate batch documentation, and maintaining a clean and compliant facility. The technician works primarily on night shifts in a 24/7 manufacturing operation and plays a key role in ensuring safe, consistent, and high-quality production.

Responsibilities

+ Clean and sanitize equipment before and after use, following established procedures to maintain a controlled cleanroom environment.

+ Perform production operations in a GMP-regulated manufacturing setting, adhering to Standard Operating Procedures and documentation requirements.

+ Make and verify connections on flow panels to support purification and production processes.

+ Perform pH and conductivity measurements to ensure process solutions meet defined specifications.

+ Prepare and perform chemical and buffer additions according to batch instructions and safety guidelines.

+ Operate ultrafiltration systems and related purification equipment to support product processing.

+ Initiate product processes on the Process Automated System, including chromatography operations using columns up to 80 cm.

+ Take and prepare product samples for testing, ensuring proper labeling, handling, and documentation.

+ Order and maintain raw material inventories, including monitoring stock levels and coordinating replenishment as needed.

+ Complete batch records accurately and in a timely manner, ensuring compliance with cGMP documentation practices.

+ Assist in training other technicians by supporting the Group Leader in demonstrating procedures, processes, and best practices.

+ Follow cleaning and sanitization procedures for equipment, tools, and cleanroom areas to maintain compliance with GMP and FDA requirements.

+ Perform general production and material handling tasks, including unloading, moving, and staging materials.

+ Use tools such as calipers and other measuring devices as needed for production or inspection activities.

+ Communicate effectively with team members and other departments to coordinate activities, resolve issues, and achieve production goals.

+ Use Personal Protective Equipment (PPE) as required and follow all safety and environmental guidelines.

+ Stand, kneel, climb, lift, pull, and carry materials as part of daily production and warehouse-related activities.

+ Investigate and resolve inventory and delivery discrepancies by using computer systems, reading and preparing reports, and coordinating with warehousing staff.

+ Support occasional after-hours and weekend work as needed to meet production schedules or handle emergency shipments, deliveries, and receipts.

Essential Skills

+ High school diploma or equivalent; an associate degree or equivalent experience is preferred.

+ Ability to work effectively in a large-scale manufacturing environment regulated by cGMP and FDA standards.

+ Familiarity with Standard Operating Procedures (SOPs) and cGMP documentation practices, even at a basic level.

+ Experience working in a cleanroom or controlled environment, or the ability to learn and follow cleanroom protocols.

+ Ability to perform cleaning and sanitization tasks using appropriate tools and chemicals.

+ Capability to lift 50+ pounds and handle materials weighing up to 75 pounds as part of daily duties.

+ Ability to work independently and as part of a team to achieve established goals and production targets.

+ Good verbal and written communication skills to follow instructions, complete documentation, and coordinate with colleagues.

+ Comfort using Personal Protective Equipment (PPE) and following safety procedures in a manufacturing and laboratory environment.

+ Reliability and flexibility to work night shifts and adjust to changing schedules, including weekends as needed.

+ Basic computer skills to operate systems used for batch records, inventory, reporting, and communication.

+ Willingness to work in a GMP-regulated, FDA-compliant environment with exposure to chemicals, human source products, and manufacturing-related conditions.

Additional

Skills & Qualifications

+ Experience in a large-scale manufacturing cGMP environment working with SOPs and cGMP documentation practices (preferred but not required).

+ Previous experience in pharmaceutical, biopharmaceutical, medical device, or medical assembly manufacturing environments.

+ Preference for candidates with plasma fractionation or purification experience.

+ Experience operating ultrafiltration systems and chromatography equipment.

+ Familiarity with inspection activities and general production or general labor tasks in a GMP environment.

+ Experience using calipers and other measuring tools in a manufacturing or laboratory setting.

+ Prior experience with…