PFF - Aseptic Filling Technician II (3rd Shift)

SHIFT: 3rd

HOURS: 11:00pm - 0730am, 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.            

 Tech 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 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)

• Operate motorized (ie Fork truck, lift jack, etc.) transport equipment for moving supplies

• 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.

Tech II

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, pasteurization, and cold box.

• Operate and filer 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.  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.

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.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

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