Sterile Manufacturing Operator

Proclinical is currently recruiting for a Sterile Manufacturing Operator with a pharmaceutical company located in King of Prussia, PA.

Job Responsibilities:

• Set-up, operate, and disinfect pharmaceutical manufacturing equipment including autoclaves, dehydrogenation tunnels, vial washers, parts washers, VHP systems, automated filling lines, cappers, vision inspection systems, and lyophilizers
• Basic knowledge of microbiology as it relates to sterile manufacturing
• Perform sanitization, disinfection, and cleaning of equipment, barriers, and GMP areas
• Perform routine troubleshooting and corrective/preventative maintenance on process equipment
• Perform routine day-to-day tasks to support sterile manufacturing activities such as ordering supplies, re-stocking areas, general upkeep, and providing support to external personnel and contractors
• 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
• Performs assigned Line Clearance activities
• Assist Product Teams in process development with issues related to aseptic processing technology or sterile manufacturing equipment
• Author technical reports and internal documents to support quality related activities
• Provides technical training for new or less experiences team members

Skills and Requirements:

• 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

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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