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Grifols Shared Services North America, Inc Fractionation Technician I / II / III - NFF (Night Shift) in Clayton, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Fractionation Technician I / II / III - NFF (12-hour, night shift schedule)

Summary:

The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, which require comprehension in the following areas: Science (i.e. biology or chemistry), Engineering, Mechanical aptitude, Computers, Various process equipment (i.e. Centrifuge, Automatic bottle opener, CIP skids) that interface with process controls automation.

Primary Responsibilities:

Tech I

● Follow company safety guidelines and programs

● Demonstrate care of facility, equipment, systems, and product

● Demonstrate appropriate personal hygiene and proper gowning

●Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's)

● Complete record keeping in accordance with current Good Manufacturing Practices

●Operate manufacturing process control system and equipment

● Operate Clean In Place (CIP) equipment

● Perform in process analytical analysis

● Monitor status of manufacturing processes

● Assist in sampling operations

● Assist in the harvest of intermediate products

● Assist in the preparation, set up and transfer of Buffer and Process solutions.

●Transfer intermediate product, raw materials, and waste

● Stage plasma, intermediate paste and raw materials

● Clean and/or Sanitize designated manufacturing areas

● Utilize SAP and / or ACSIS transactions

● Support the supply chain requirements for production

● Assist team members, including supervision, to perform additional tasks

● Work in an ethical and compliant manner to manufacture a drug product that is safe for human use.

Tech II

In addition to previously stated responsibilities for Tech I:

● Calibrate analytical equipment for routine use

● Perform DCS setup and monitor setup for manufacturing processes

● Perform sampling operations as required by procedure

● Harvest intermediate products

● Perform proper double checks as required

● Prepare, set up and transfer Buffer and process solutions

● Develop troubleshooting skills for equipment and automation systems

● Perform training for lesser qualified employees

● Assist team members, including supervision, to perform additional tasks

● Perform GMP and safety audits

Tech III

In addition to previously stated responsibilities for Tech I & II:

● Enforce safety guidelines and operate established safety programs

● Lead team safety meetings

● Complete and review record keeping in accordance with current Good Manufacturing Practices

● Approve and issue controlled documents

● Calibrate and troubleshoot analytical equipment

● Perform in process analytical analysis

● Perform DCS setup and history retrieval for manufacturing processes

● Assist Coordinator in scheduling processes, personnel and equipment

● Stand in for Coordinator as needed

● Perform operations within Maximo

● Review trends to ensure process parameters are within expected ranges

● Participate in the investigation and resolution of incidents.

● Job performance displays initiative and requires minimal supervision

● Support the supply chain requirements for production with minimal supervision

Additional Responsibilities:

Tech I

● Completes assignments in functional areas supporting departmental objectives.

● Communicates effectively and promptly with other operators, technicians and supervisors.

Tech II & Tech III

In addition to previously stated responsibilities for Tech I:

● Maintains proper documentation.

Knowledge, Skills, & Abilities:

Tech I

● Knowledge of safety guidelines and SOP's established by the company.

● Strong knowledge of current Good Manufacturing Practices (cGMP), and State and Federal Health, Environment and Safety regulations.

● Excellent oral and written communication skills.

● Comfortable with using different computer systems to perform data entry.

● Willingness to work with and learn from other members of the manufacturing team.

● Desire to enhance one’s skills and knowledge.

Tech II & Tech III

In addition to previously stated knowledge, skills, & abilities for Tech I:

● Strong critical thinking and problem solving skills.

● Ability to identify errors and provide corrective actions.

● Develop and maintain necessary skills to stay current with current role and the work environment.

● Ability to train others a plus

Requirements:

Tech I

● High school education and completion of the "Bioworks Certification Program" through a community college or

● High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC)

● Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum (completion of the Bioworks Certificate program through a community college a plus).

Additional work experience(s) to be considered to support "Technician" position qualification(s):

● Ability to diagnose and troubleshoot process equipment used in manufacturing environment preferred

● Work experience with distributed control systems and PLC operated equipment preferred

● Experience in protein separation preferred

● Start-up or validation experience preferred

Tech II

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 work experience(s) to be considered to support "Technician II" level qualifications:

● Ability to diagnose and troubleshoot process equipment used in manufacturing environment required

● Experience in protein separation preferred

● Experience in the pharmaceutical and/or biotechnology industry in any of the following: start-up, validation, asceptic processing, sampling techniques preferred

● Delta V experience preferred

● Completion of the Bioworks Certificate program through a community college preferred

Tech III

Requires 12 months as a Technician II and on target for a PMP rating of "Achieves Expectations" or 9 months as a Technician II and on target for a PMP rating of "Exceeds Expectations" level.

Additional work experience(s) to be considered to support "Technician III" level qualification(s):

● Ability to independently diagnose and troubleshoot process equipment used in manufacturing environment required

● Distributed Control Systems (DCS) and/or centrifugation experience required

● Experience in protein separation preferred

● SAP and Maximo experience preferred

● Start-up or validation experience preferred

● Completion of the "Bioworks Certification Program" through a community college preferred

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Occupational Demands:

● Work is performed in a laboratory / manufacturing environment.

● Work schedule requires shift rotation and weekends.

● Exposure to biological fluids with potential exposure to infectious organisms.

● Exposure to electrical and pneumatic powered equipment.

● Exposure to miscellaneous production chemicals, moving machinery and production equipment.

● Potential exposure to high levels of noise on production floor.

● Occasional exposure to -20°C temporary storage freezer in association with storage and retrieval of Plasma and Intermediate paste.

● Personal protective equipment required such as protective eyewear, garments, gloves, safety shoes, head protection, and hearing protection.

● Frequently sits for 4-6 hours per day.

● Frequently walks during working shift.

● Frequent repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

● Often performs duties standing.

● Frequently bends and twists at neck and waist.

● Light to moderate lifting and carrying objects with a maximum lift of 50 lbs.

● Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through

● Frequently interacts with others, i.e. co-workers, support staff, manager / supervisor.

● Occasional entry into confined spaces, requiring kneeling, climbing and squatting.

● Occasionally works at elevated heights on equipment access platforms and/or ladders.

● Work activities require safe and precise coordinated movements.

EEO/Minorities/Females/Disability/Veterans

Req ID: 315107

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