Sterile Manufacturing Operator

Highly Competitive Salary
  1. Permanent
  2. Biological Sciences, Laboratory Technician, Molecular Biology
  3. United States
King of Prussia, USA
Posting date: 13 Jul 2020
SC.B.30489

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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