Senior Production Operator

The Senior Production Operator will play a key role in the execution of manufacturing activities for Drug Substance (DS) and Drug Product (DP) and Filling within a GMP-compliant clinical manufacturing environment.

Requirements

• Support commissioning and qualification tasks
• Author process equipment operations and other related manufacturing related SOPs and documentation
• Review / develop and provide operability feedback process automation recipes with engineering team
• Review and provide operability feedback on Single Use Systems (SUS) used in process equipment
• Review / develop and provide operability feedback MES recipes that minimize human error
• Prepare for the site’s GMP readiness
• Execute manufacturing activities for Drug Substance (DS) and Drug Product (DP), including filling, while operating, monitoring, and troubleshooting equipment according to established procedures and GMP guidelines
• Perform in-process checks and sampling to ensure product quality and compliance with specifications, and accurately document all manufacturing activities
• Ensure compliance with GMP, quality, safety, and work regulations during all manufacturing activities, maintaining cleanliness and organization of production areas in line with GMP standards
• Identify, report, and support investigations into deviations, non-conformances, or equipment malfunctions, assisting in implementing corrective and preventive actions (CAPAs)
• Collaborate with the Production Manager and cross-functional teams to ensure smooth production operations, communicating issues or observations that may impact production quality, timelines, or efficiency
• Provide feedback and suggestions to improve manufacturing processes and efficiency, assisting in the implementation and monitoring of process improvements and CAPAs
• Review manufacturing documentation for accuracy, completeness, and compliance, and support the creation and review of GMP-relevant documents such as SOPs and deviation reports
• Mentor junior production operators, providing guidance and training on processes and GMP requirements, and assist in onboarding and training new team members

Benefits

• Competitive remuneration packages
• Flexible benefits