PFF Aseptic Filling Tech I/II

Join an international team working to improve the future of healthcare and 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, developing, producing, and marketing innovative medicines, solutions, and services in more than 110 countries and regions.

About the role

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 II independently performs these tasks and is expected to recognize and identify safety hazards, perform basic training to less experienced personnel, and utilize troubleshooting skills.

Schedule

2nd Shift: 3:00 PM - 11:30 PM, Monday - Friday

Responsibilities

Technician I

• 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
• Detailed, general facility housekeeping (minor cleaning, keeping work and production areas neat and free from clutter, etc.)
• Cleaning and sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
• Operate motorized transport equipment (e.g., forklift, lift jack) for moving supplies
• Real-time documentation (e.g., BPR) during production runs and maintain accurate records/logs
• Monitor and operate various computer control systems for production activities (e.g., SCADA and Andover)

Technician II

• Prepares and properly labels according to BPR and non-routine requests
• Independently interprets and utilizes information from company support systems
• Maintains 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
• Demonstrates department-specific aseptic techniques and capabilities
• Performs all duties described at the Aseptic Filling Level
• Accurate documentation skills and basic computer skills
• Mechanical aptitude and ability to work well with others in a team environment
• Self-starter with the ability to work independently and use good judgment
• Able to handle multiple priorities with a proactive, results-oriented approach 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
• Train less experienced Technicians in the use of applicable computer systems

Requirements

• High School Diploma (Bioworks Certification preferred)
• 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
• 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

Work Environment

• 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 (e.g., protective eyewear, chemical suits, safety shoes, 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 15-44 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; 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

Internal Candidate Requirements

• 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"
• 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