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Job type: Permanent

Discipline: Biological Sciences, Laboratory Technician, Molecular Biology

Location: United States

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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