Aseptic Filling Technician I/II (3rd Shift)

Grifols; Clayton (NC); On-site; USD 30,000 - 41,000; Full time

Job summary

Grifols is hiring an Aseptic Filling Technician I/II for the 3rd shift in Clayton, NC. The role supports aseptic fill operations in a GMP biologics environment, performing disassembly and reassembly of equipment, cleaning, and real-time documentation. You will assist with process controls and use SCADA/Andover systems.

The Technician I/II will work with stringent gowning, maintain logs, and ensure adherence to safety and quality standards while contributing to a high-volume production line.

Qualifications

• High school diploma required; Bioworks certification preferred.
• Must be able to work 3rd shift (11:00 PM – 7:30 AM) and lift up to 50 lbs.
• Experience in GMP manufacturing and aseptic environments is desirable.

Responsibilities

• Set up and operate aseptic fill equipment in a biologics environment.
• Gowning in Class A/B and maintain cleanliness of fill suites.
• Perform cleaning, sanitization, and equipment maintenance per procedures.
• Document processes in real time and record logs accurately.
• Monitor computer control systems (SCADA/Andover) during production.

Skills

Math aptitude

Mechanical aptitude

Attention to detail

Teamwork

Documentation skills

Physical endurance

Education

High School Diploma

Bioworks Certification preferred

Tools

SCADA

Andover control system

Job description

Aseptic Filling Technician I/II (3rd Shift)

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

SFF- Aseptic Filling Technician I/II

SHIFT: 3rd

HOURS: 11:00PM 07:30AM Monday-Friday

Summary-

The Technician I is an entry level Aseptic Fill technician role that performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician I will routinely disassemble, clean, and reassemble equipment for production activities, assist with process control manipulations, use various computer control systems and analytical equipment. Perform real time documentation in appropriate production procedures while maintaining accurate records and logs.

Responsibilities:

• Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals
• Class A/B gowning qualified for facility cleaning of fill suites
• Operate support fill equipment such as the glass inspection stations, rinser/tunnel, VAM and over sealer. Load carts with vials or syringes
• Perform SIPOperations and filter integrity testing
• Prepare chemical solution for production use. Strict adherence to Dept. Safety Rules.
• Perform material handling and glass inspection activities
• Detailed, general facility housekeeping i.e. minor cleaning, keeping work and production area neat and free from clutter, etc.
• Cleaning - Sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
• Real time documentation (i.e. BPR) during production run and maintain accurate records/logs
• Monitor and operate various computer control systems for production activities i.e. SCADA and Andover

Summary-

The Technician II independently performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician II will independently dissemble, clean, and reassemble equipment for production activities, perform process control manipulations, use various computer control systems and analytical equipment to perform real time documentation in appropriate production procedures while maintaining accurate records and logs. The Technician II will be expected to recognize and identify safety hazards, perform basic training to less experienced personnel, and utilize troubleshooting skills in alignment with job responsibilities.

Responsibilities

• Prepares and properly labels according to BPR and non-routine request
• Independently interprets and utilizes information from company support systems
• Maintaining all training responsibilities associated with the Technician II level
• May operate and monitor final container lyophilization, heat treatment, pasteurizationand cold box.
• Operate and filer integrity tester and gas chromatography for lexsol detection
• Demonstrates department specificaseptic techniques and capabilities
• Performs all duties described atthe Aseptic Filling Level
• Accurate documentation skills. Basic computer skills. Mechanical aptitude. Ability to work well with others in a team environment. Self-starter with the ability to work independently and use good judgement. Able to handle multiple priorities. Proactive, results oriented, and strong attention to detail.
• Maintain acceptable aseptic gowning qualification and media fill certification.
• Setup and operate equipment within an aseptic environment
• Utilize troubleshooting skills in alignment with job scope responsibilities to provide solutions
• Assist with initial responsibilities for the Technician level. Trains less experienced Technicians in the use of applicable computer systems.

Knowledge, skills & abilities:

Must possess a good math and mechanical aptitude with the ability to perform skills in an aseptic environment. Production work experience in a high-volume manufacturing environment is desired. Must be able to function in an aseptic environment while maintaining the sterility of the product. Able to work effectively and efficiently as a member of a team. Able to lift up to 50 pounds. Continuous standing, walking and some bending is required. Off shift and overtime work may be necessary.

Requirements:

• High School Diploma. Bioworks Certification preferred.

Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling and squatting. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed sitting for 4-6 hours per day. Occasionally walks, stands and bends waist for 2-4 hours per day. Frequent hand movement of one hand with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying of 15-44lbs. for 1-2 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures.

Experience

Internal Candidate Requirement: Requires 12 months as a Technician and on target for a PMP rating of "Achieves Expectations" or 9 months as a Technician and on target for a PMP rating of "Exceeds Expectations" level. In addition, required for Filling employees: Certified to operate in the fill room and able to operate aseptic fill environment equipment such as the fill machine and ALUS independently.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.