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Job Description:
Set-up, operate, and disinfect pharmaceutical manufacturing equipment including autoclaves, depyrogenation tunnels, vial washers, parts washers, VHP systems, automated filling lines, cappers, vision inspection systems, and lyophilizers.
Perform sanitization, disinfection, and cleaning of equipment, barriers, and GMP areas.
Perform routine troubleshooting and corrective/preventative maintenance on process equipment.
Visually inspects parenteral products
Write and maintain standard operating procedures (SOPs) for manufacturing equipment.
Assist with validation, change controls, and quality investigations
Actively participates in GEMBAs, & RCAs; contribute to a continuous improvement culture
Actively participates in the safety program and live the Living Safety culture
Performs assigned Line Clearance activities
Assist Product Teams in process development with issues related to aseptic processing technology or sterile manufacturing equipment.
Provides technical training for new or less experiences team members.
Perform all work in strong alignment with the Client Behaviour Expectations
Notify supervisor immediately of any quality or safety risks or concerns.
Competencies:
Minimum High School Diploma; additional technical training and/or certification preferred
Minimum 3 years of experience working in a clinical scale aseptic manufacturing environment, or equivalent.
Good written and oral communication skills, including proficiency in MS Office.
Proven teamwork and organizational skills, including demonstrated leadership ability.
Ability to function independently.
Experience in the hands-on use of equipment and processes to manufacture sterile drug products.
Experience visually inspecting parenteral products.
Thorough knowledge of and experience working with cGMP and documentation principals for the manufacture of sterile drug products, or similar highly regulated environment.
Strong knowledge of aseptic techniques and sterility assurance in aseptic processing.
Basic knowledge of microbiology as it relates to sterile manufacturing
*//
EEO Employer
Minorities/ Females/ Disabled/ Veterans/ Gender Identity/ Sexual Orient
//*
Job Description:
Set-up, operate, and disinfect pharmaceutical manufacturing equipment including autoclaves, depyrogenation tunnels, vial washers, parts washers, VHP systems, automated filling lines, cappers, vision inspection systems, and lyophilizers.
Perform sanitization, disinfection, and cleaning of equipment, barriers, and GMP areas.
Perform routine troubleshooting and corrective/preventative maintenance on process equipment.
Visually inspects parenteral products
Write and maintain standard operating procedures (SOPs) for manufacturing equipment.
Assist with validation, change controls, and quality investigations
Actively participates in GEMBAs, & RCAs; contribute to a continuous improvement culture
Actively participates in the safety program and live the Living Safety culture
Performs assigned Line Clearance activities
Assist Product Teams in process development with issues related to aseptic processing technology or sterile manufacturing equipment.
Provides technical training for new or less experiences team members.
Perform all work in strong alignment with the Client Behaviour Expectations
Notify supervisor immediately of any quality or safety risks or concerns.
Competencies:
Minimum High School Diploma; additional technical training and/or certification preferred
Minimum 3 years of experience working in a clinical scale aseptic manufacturing environment, or equivalent.
Good written and oral communication skills, including proficiency in MS Office.
Proven teamwork and organizational skills, including demonstrated leadership ability.
Ability to function independently.
Experience in the hands-on use of equipment and processes to manufacture sterile drug products.
Experience visually inspecting parenteral products.
Thorough knowledge of and experience working with cGMP and documentation principals for the manufacture of sterile drug products, or similar highly regulated environment.
Strong knowledge of aseptic techniques and sterility assurance in aseptic processing.
Basic knowledge of microbiology as it relates to sterile manufacturing
*//
EEO Employer
Minorities/ Females/ Disabled/ Veterans/ Gender Identity/ Sexual Orient
//*
