NFF - Fractionation Technician I/II - Night Shift

Grifols; North Carolina; On-site; USD 32,000 - 40,000; Full time

Job summary

Grifols is seeking a Fractionation Technician I / II for night shift in Clayton, NC to manufacture products from human plasma. You will operate CIP/SAP systems, monitor processes, and ensure adherence to cGMP and safety standards.

The ideal candidate has a High School Diploma (Bioworks certification preferred), strong analytical and computer skills, and a proactive attitude to support regulated production and teams.

Qualifications

• High School Diploma. Bioworks Certification preferred.
• Knowledge of safety guidelines and SOP's established by the company.
• Strong knowledge of cGMP and relevant health, environment and safety rules.
• Excellent oral and written communication skills.
• Comfortable with using different computer systems to perform data entry.
• Willingness to work with and learn from other manufacturing team members.
• Desire to enhance skills and knowledge.

Responsibilities

• Follow company safety guidelines and programs.
• Operate manufacturing process control system and equipment.
• Operate CIP equipment.
• Perform in process analytical analysis.
• Monitor status of manufacturing processes.
• Assist in sampling operations.
• Work in an ethical and compliant manner to manufacture a drug product.

Skills

Safety guidelines

cGMP knowledge

Communication skills

Data entry

Teamwork

Education

High School Diploma

Bioworks Certification preferred

Tools

SAP

ACSIS

Job description

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.

NFF- Fractionation Technician I / II

Night Shift- 7pm-7am

Summary

The Fractionation Technician I / II 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 For Role

• 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.

Additional Responsibilities

• Completes assignments in functional areas supporting departmental objectives.
• Communicates effectively and promptly with other operators, technicians and supervisors.

Knowledge, Skills And Abilities

• 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.

Education/Experience

• High School Diploma. Bioworks Certification preferred.

Equivalency

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

Occupational Demands

• Work is performed in a laboratory/manufacturing environment.
• 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.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Requires kneeling, climbing and squatting.
• Frequently sits for 4-6 hours per day.
• 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 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 spoken and written words and sentences.
• Frequently interacts with others.
• Rotating shifts.
• Works at heights on platforms and/or on ladders.

Work is 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 and to dust/gas/fumes/steam. Exposure to extreme cold below 32*. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. 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 standing, walking and bending neck for 6-8 hours per day. Frequently sits for 4-6 hours per day. Frequent movement of both hands 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. Occasionally bends and twists neck and waist. Light lifting of 15lbs for 2-4 hours per day with a maximum lift of 50lbs. Hearing acuity essential. Color perception/discrimination, and 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 routine tasks by following a set of written or oral instructions/procedures.

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

Learn more about Grifols