Job Description

The Lab Technician supports large-scale biopharmaceutical production by operating, cleaning, and maintaining process equipment in a cGMP-regulated environment. This role focuses on fractionation, ultrafiltration, chromatography, and buffer preparation while ensuring strict adherence to Standard Operating Procedures and documentation practices. The technician works in a controlled cleanroom and manufacturing setting, performing both routine and complex tasks to maintain product quality, safety, and regulatory compliance during night shift operations.

Responsibilities

• Clean and sanitize production and laboratory equipment before and after use in accordance with cGMP and SOP requirements.
• Perform production operations related to fractionation and biopharmaceutical manufacturing in a regulated environment.
• Make, verify, and secure process connections on flow panels to ensure proper product and buffer routing.
• Perform pH and conductivity measurements on in-process solutions and document results accurately.
• Prepare and perform chemical and buffer additions according to batch records and process instructions.
• Operate ultrafiltration systems to concentrate and diafilter products as required by process specifications.
• Initiate and monitor product processes using the Process Automated System, following established procedures.
• Set up, operate, and monitor chromatography processes, including systems using columns up to 80 cm, to support purification activities.
• Take, label, and prepare product samples for in-process testing and quality control analysis.
• Order, receive, and maintain raw material inventories to ensure uninterrupted production operations.
• Complete batch records, logs, and associated cGMP documentation with accuracy, clarity, and compliance.
• Assist with inspection, general production, unloading, and other manufacturing or warehouse-related tasks as needed.
• Support the Group Leader or sr staff in training other technicians on procedures, equipment use, and documentation practices.
• Follow Standard Operating Procedures and cGMP documentation practices to maintain regulatory compliance.
• Use cleaning tools and chemicals safely to maintain a controlled cleanroom and production environment.
• Handle medical device, pharmaceutical, and biopharmaceutical components with care and according to quality standards.
• Use calipers and other measuring tools when required for production or inspection activities.
• Lift, move, and carry materials and equipment, including heavy items, to support production and warehouse operations.
• Communicate effectively with warehousing staff and other departments to resolve inventory and delivery discrepancies.
• Read and prepare reports in accordance with departmental SOPs, using computer systems and related software as needed.
• Adhere to all safety, PPE, and environmental requirements, including working safely around chemicals, caustics, fumes, and human source products.

Essential Skills

• High school diploma or Associate degree or equivalent experience preferred.
• Ability to work in a large-scale manufacturing environment regulated by cGMP standards.
• Familiarity with working under Standard Operating Procedures and cGMP documentation practices (experience is a plus, not a requirement).
• Experience or strong interest in pharmaceutical, medical device, or biopharmaceutical manufacturing environments.
• Ability to perform cleaning and sanitization tasks in cleanroom and production areas.
• Comfort working in a cleanroom and controlled environment with strict cleanliness and documentation requirements.
• Capability to perform general production and general labor tasks, including unloading and material handling.
• Ability to lift 50+ pounds routinely and up to 75 pounds occasionally, including lifting, pulling, and carrying materials.
• Good verbal and written communication skills for documenting processes and interacting with cross-functional teams.
• Ability to work independently and as part of a team to meet production and quality objectives.
• Reliable attendance and ability to work flexible hours, including nights and some weekends, as needed.
• Ability to use Personal Protective Equipment (PPE) consistently and correctly.
• Comfort working around chemicals, caustics, fumes, airborne particles, odors, and human source products in a regulated environment.
• Basic computer skills to operate software for batch records, inventory, reporting, and communication.

Work Environment