Job description
Mantell Associates is partnered with a leading Biosimilars organisation in their search for a Drug Product Operator.
Drug Product Operator - Responsibilities:
Operate and monitor filling line equipment, including but not limited to vial filling machines, stoppering machines, capping machines, and labeling equipment
Set up and calibrate equipment according to standard operating procedures (SOPs)
Troubleshoot equipment issues and perform routine maintenance tasks
Execute filling processes in accordance with batch records and established procedures
Ensure accurate and precise filling of drug products, adhering to specified volumes and concentrations
Monitor and control critical process parameters to maintain product quality
Conduct in-process checks to verify product quality during the filling process
Participate in the collection of samples for quality control testing
Follow GMP guidelines to maintain a clean and controlled manufacturing environment
Document all activities accurately and in compliance with regulatory requirements
Complete batch records, logbooks, and any other required documentation
Adhere to safety protocols and ensure a safe working environment for yourself and others
Comply with regulatory guidelines, including FDA and other relevant authorities
Collaborate with other team members, including technicians, quality control personnel, and supervisors
Report any deviations, issues, or concerns to the appropriate personnel
Drug Product Operator - Requirements:
High school diploma or equivalent; additional technical or vocational training is a plus
Previous experience in pharmaceutical manufacturing or a related industry
Familiarity with GMP and other regulatory requirements
Strong attention to detail and precision in executing tasks
Ability to follow written instructions and SOP
Shift work
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.