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Sterile Manufacturing Associate
- Permanent
- Molecular Biology, Pharmacology
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Sterile Manufacturing Associate with a pharmaceutical company located in Upper Merion, PA.
Job Responsibilities:
- 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
- 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.
- Notify supervisor immediately of any quality or safety risks or concerns.
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.
- Basic knowledge of microbiology as it relates to sterile manufacturing.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
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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