Job Information
Grifols Shared Services North America, Inc Fractionation Technician - NFB (Days) in Clayton, North Carolina
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.
12-hour shift
The Fractionation Technician III 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
Enforce safety guidelines and operate established safety programs
Lead team safety meetings
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)
Approve and issue controlled documents
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.
Executes commissioning and validation activities associated with a new building.
Perform GMP and safety audits.
This job description is intended to present the general content and requirements for the performance of this job. This description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Additional Responsibilities:
Communicates effectively and promptly to other operators, technicians, supervisors, and managers.
Completes assignments in functional areas supporting departmental objectives.
Maintains proper documentation.
Knowledge, skills & 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.
Ability to work a 24/7 rotating shift schedule.
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.
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.
Education/Experience Requirements:
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 Experience:
Additional work experience(s) to be considered to support "Technician" position 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.
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.
Capable of adapting to a fluid schedule during commissioning and validation.
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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 524775
Type: Regular Full-Time
Job Category: Manufacturing