Filling Process Engineer
The Filling Process Engineer will be responsible for overseeing and optimizing the drug product filling processes within our GMP facility.
This individual will play a key role in maintaining strict adherence to cGMP guidelines, ensuring the safety and efficacy of the drug products, and meeting production targets.
The ideal candidate will have a strong background in engineering principles, process optimization, and operating within a clean room environment.
As a critical member of the manufacturing team, the Filling Process Engineer will actively contribute to the success of our clinical and commercial production operations.
Responsibilities include:
Process Optimization:
Continuously improve filling processes to enhance efficiency, reduce waste, and increase output while maintaining compliance with regulatory requirements and quality standards.
Equipment Management:
Oversee and maintain filling equipment, ensuring proper functionality, calibration, and performance.
Collaborate with the maintenance team for preventive maintenance and troubleshooting.
Clean Room Compliance:
Operate within ISO Class 5 and 7 clean rooms, adhering to aseptic techniques, gowning procedures, and proper cleaning protocols to prevent contamination.
Quality Control:
Collaborate with the Quality Assurance team to implement and monitor quality control measures, conduct investigations, and implement corrective and preventive actions (CAPAs) as necessary.
Documentation and Reporting:
Maintain accurate and up-to-date records of all filling processes, equipment logs, and batch documentation in compliance with GMP guidelines.
Training:
Train and mentor junior staff members on filling processes, equipment operation, and clean room practices to ensure a skilled and knowledgeable workforce.
Regulatory Compliance:
Stay up to date with relevant regulations, guidelines, and industry best practices related to drug product filling and clean room operations.
Continuous Improvement:
Identify opportunities for process improvements, cost reduction, and increased productivity.
Drive and participate in process optimization projects.
Safety:
Promote a safety-conscious culture within the clean room environment and adhere to all safety protocols and procedures.
Cross-Functional Collaboration:
Collaborate effectively with other departments, such as PD, Quality Control, and Technical Support, to ensure seamless coordination and timely completion of projects.
Who You Are:
Minimum
Qualifications:
Bachelor's Degree in Industrial Engineering, Chemical Engineering, Pharmaceutical Sciences, or other Engineering discipline 4
years of experience in a GMP environment, specifically in drug product filling processes and clean room operations Preferred
Qualifications:
Master's Degree in Industrial Engineering, Chemical Engineering, Pharmaceutical Sciences, or other Engineering disciplineStrong understanding of cGMP guidelines and FDA regulations pertaining to pharmaceutical manufacturingProficiency in process optimization, equipment management, and aseptic techniques within clean room environmentsProven ability to identify and resolve technical issues related to filling processes and equipmentExcellent interpersonal and communication skills with the ability to work collaboratively in cross-functional teamsData-driven approach to decision-making, with the ability to analyze and interpret process data effectivelyDemonstrated flexibility to work in a fast-paced, dynamic environment with changing priorities and tight deadlines Recommended Skills Calibration Chemical Engineering Clinical Works Communication Corrective And Preventive Action (Capa) Decision Making Estimated Salary: $20 to $28 per hour based on qualifications.
This individual will play a key role in maintaining strict adherence to cGMP guidelines, ensuring the safety and efficacy of the drug products, and meeting production targets.
The ideal candidate will have a strong background in engineering principles, process optimization, and operating within a clean room environment.
As a critical member of the manufacturing team, the Filling Process Engineer will actively contribute to the success of our clinical and commercial production operations.
Responsibilities include:
Process Optimization:
Continuously improve filling processes to enhance efficiency, reduce waste, and increase output while maintaining compliance with regulatory requirements and quality standards.
Equipment Management:
Oversee and maintain filling equipment, ensuring proper functionality, calibration, and performance.
Collaborate with the maintenance team for preventive maintenance and troubleshooting.
Clean Room Compliance:
Operate within ISO Class 5 and 7 clean rooms, adhering to aseptic techniques, gowning procedures, and proper cleaning protocols to prevent contamination.
Quality Control:
Collaborate with the Quality Assurance team to implement and monitor quality control measures, conduct investigations, and implement corrective and preventive actions (CAPAs) as necessary.
Documentation and Reporting:
Maintain accurate and up-to-date records of all filling processes, equipment logs, and batch documentation in compliance with GMP guidelines.
Training:
Train and mentor junior staff members on filling processes, equipment operation, and clean room practices to ensure a skilled and knowledgeable workforce.
Regulatory Compliance:
Stay up to date with relevant regulations, guidelines, and industry best practices related to drug product filling and clean room operations.
Continuous Improvement:
Identify opportunities for process improvements, cost reduction, and increased productivity.
Drive and participate in process optimization projects.
Safety:
Promote a safety-conscious culture within the clean room environment and adhere to all safety protocols and procedures.
Cross-Functional Collaboration:
Collaborate effectively with other departments, such as PD, Quality Control, and Technical Support, to ensure seamless coordination and timely completion of projects.
Who You Are:
Minimum
Qualifications:
Bachelor's Degree in Industrial Engineering, Chemical Engineering, Pharmaceutical Sciences, or other Engineering discipline 4
years of experience in a GMP environment, specifically in drug product filling processes and clean room operations Preferred
Qualifications:
Master's Degree in Industrial Engineering, Chemical Engineering, Pharmaceutical Sciences, or other Engineering disciplineStrong understanding of cGMP guidelines and FDA regulations pertaining to pharmaceutical manufacturingProficiency in process optimization, equipment management, and aseptic techniques within clean room environmentsProven ability to identify and resolve technical issues related to filling processes and equipmentExcellent interpersonal and communication skills with the ability to work collaboratively in cross-functional teamsData-driven approach to decision-making, with the ability to analyze and interpret process data effectivelyDemonstrated flexibility to work in a fast-paced, dynamic environment with changing priorities and tight deadlines Recommended Skills Calibration Chemical Engineering Clinical Works Communication Corrective And Preventive Action (Capa) Decision Making Estimated Salary: $20 to $28 per hour based on qualifications.
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