Fractionation Technician - NFB (Days)
Grifols, S.A, Clayton, NC, United States
Schedule
12‑hour shift – Nights
Job Title
Fractionation Technician
Primary Responsibilities
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 (SOPs) and complete Batch Production Records (BPRs)
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
Execute commissioning and validation activities associated with a new building
Additional Responsibilities
Completes assignments in functional areas supporting departmental objectives
Communicates effectively and promptly with other operators, technicians, and supervisors
Knowledge, Skills & Abilities
Knowledge of safety guidelines and SOPs 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
Education & Experience Requirements
High school education and completion of the “Bioworks Certification Program” through a community college
High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years (completion of the “Bioworks Certification Program” through a community college a plus)
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 Experience
Ability to diagnose and troubleshoot process equipment used in a manufacturing environment preferred
Work experience with distributed control systems and PLC‑operated equipment preferred
Start‑up or validation experience preferred
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
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
Benefits
We offer a comprehensive package of benefits including medical, paid time off (PTO), annual bonus, pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401(k) match, and tuition reimbursement.
Equal Employment Opportunity
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.
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12‑hour shift – Nights
Job Title
Fractionation Technician
Primary Responsibilities
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 (SOPs) and complete Batch Production Records (BPRs)
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
Execute commissioning and validation activities associated with a new building
Additional Responsibilities
Completes assignments in functional areas supporting departmental objectives
Communicates effectively and promptly with other operators, technicians, and supervisors
Knowledge, Skills & Abilities
Knowledge of safety guidelines and SOPs 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
Education & Experience Requirements
High school education and completion of the “Bioworks Certification Program” through a community college
High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years (completion of the “Bioworks Certification Program” through a community college a plus)
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 Experience
Ability to diagnose and troubleshoot process equipment used in a manufacturing environment preferred
Work experience with distributed control systems and PLC‑operated equipment preferred
Start‑up or validation experience preferred
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
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
Benefits
We offer a comprehensive package of benefits including medical, paid time off (PTO), annual bonus, pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401(k) match, and tuition reimbursement.
Equal Employment Opportunity
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.
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