Aseptic Filling Technician 2nd Shift

Grifols, S.A; Clayton (NC); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Employee Referral Bonus Eligible

Job summary

Grifols, S.A. in Clayton, NC seeks a Technician II for a biologics filling operation. You will set up and operate fill equipment in an aseptic environment, perform SIP/PBC operations, and ensure cleanroom compliance with strict documentation.

The role requires either an associate or bachelor's degree or Bioworks Certification, plus one year of regulated industry experience. Lifting up to 50 lbs and overtime may be necessary.

Qualifications

• One year of regulated industry experience (FDA, USDA, NRC) or related degree/certification.
• Able to work in an aseptic environment with sterilized processes.
• May operate and monitor fill equipment and related systems.

Responsibilities

• Set up and operate fill equipment independently in aseptic environments.
• Operate and monitor glass inspection, rinser/tunnel, VAM and over sealer.
• Perform SIP/PBC operations and filter integrity testing.
• Prepare chemical solutions and maintain safety procedures.
• Maintain logs and real-time documentation during production.

Skills

Math & mechanical aptitude

Teamwork

Aseptic techniques

Education

Associate's or Bachelor's degree

Bioworks Certification Program

Job description

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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: 03:00PM - 11:30PM Monday-Friday

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 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

Responsibilities:

Performs all duties described at the Technician level

Fill room qualified with the ability to setup and operate fill equipment independently in an aseptic environment. Demonstrates department specific aseptic techniques and capabilitiesMay operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box.

Operate filter integrity tester

Prepares and properly labels samples according to BPR and non-routine requestsIndependently interprets and utilizes information from company support systems

Assist with initial training responsibilities for the Technician level. Trains less experienced Technicians in the use of applicable computer systems

Maintain their acceptable aseptic gowning qualification and media fill certification

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:

• One year of regulated industry (FDA, USDA, NRC) experience ORGraduation from an accredited college/university with an Associate's or Bachelor's degree OR Completion of the Bioworks Certification Program preferred

Tech II: In addition to the requirements listed above, the Aseptic Filling Technician II typically requires one year of experience as an Aseptic Filling Technician.

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.

Employee Referral Bonus Eligible

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.