PFF - Filling Technician I/II (2nd Shift)

PFF - Filling Technician I/II (2nd 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. Shift: 2nd Hours: 3:00pm‑11:30pm, Monday‑Friday Technician I Summary The Technician I is an entry‑level aseptic fill technician who performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician I routinely disassembles, cleans, and reassembles equipment for production activities, assists with process control manipulations, uses various computer control systems and analytical equipment, and performs real‑time documentation in appropriate production procedures while maintaining accurate records and logs. Technician I 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 SIP/PBC operations and filter‑integrity testing. Prepare chemical solutions for production use. Strict adherence to department safety rules. Perform material handling and glass inspection activities. Maintain detailed general facility housekeeping (minor cleaning, keeping work and production area neat and free from clutter, etc.). Sanitization per procedures; documentation of sanitization, mopping, disinfecting floors, walls and 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). Technician II Summary The Technician II independently performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician II disassembles, cleans, and reassembles equipment for production activities, performs process control manipulations, uses 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 recognizes and identifies safety hazards, performs basic training for less experienced personnel, and utilizes troubleshooting skills in alignment with job responsibilities. Technician II Responsibilities Prepare and properly label items according to BPR and non‑routine requests. Independently interpret and utilize information from company support systems. Maintain all training responsibilities associated with the Technician II level. May operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box. Operate filter‑integrity tester and gas chromatography for lexsol detection. Demonstrate department‑specific aseptic techniques and capabilities. Perform all duties described at the aseptic filling level. Demonstrate accurate documentation skills, basic computer skills, mechanical aptitude, ability to work well with others in a team environment, self‑starter with ability to work independently and use good judgment, ability to handle multiple priorities, proactive, results‑oriented, and strong attention to detail. Maintain acceptable aseptic gowning qualification and media‑fill certification. Set up 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; train less experienced Technicians in the use of applicable computer systems. Knowledge, Skills & Abilities Good math and mechanical aptitude with the ability to perform skills in an aseptic environment. Production work experience in a high‑volume manufacturing environment desirable. Ability to function in an aseptic environment while maintaining the sterility of the product. Ability to work effectively and efficiently as a member of a team. Ability to lift up to 50 pounds; continuous standing, walking, and some bending required. Off‑shift and overtime work may be necessary. Requirements High School Diploma. Bioworks certification preferred. Work performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, 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 (protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection, respirator). Work 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 ability to make fast, simple movements of the fingers, hands, and wrists. Ability to make precise coordinated movements to grasp and manipulate objects. Light to moderate lifting and carrying of 15‑44 lbs for 1‑2 hours per day with a maximum lift of 50 lbs. 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. Additional requirements 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. #J-18808-Ljbffr Grifols, S.A