Fractionation Lab Technician (Night Shift

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

Lab Technician (Night Shift)

Job Description

The Lab Technician (Night Shift) 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.

+ Work collaboratively with team members and independently to achieve established production and quality goals.

+ Support flexible scheduling needs, including occasional after-hours and weekend work, to meet production demands.

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.

Additional

Skills & Qualifications

+ Preference for candidates with experience in plasma fractionation or purification processes.

+ Experience in a large-scale cGMP manufacturing environment working with SOPs and cGMP documentation practices is…