Manufacturing Technician II

Location: Rockville, MD
Date Posted: 01-10-2018
The associate in this position is expected to possess a clear understanding of the fill finish operations.  This position involves aseptic fill operations using isolator technology, visual inspection, labeling, and packaging as per GMP regulations.  The candidate will also be interacting with cross-functional departments to troubleshoot, request materials, and to overcome challenges in meeting the production schedule. Previous experience in cGMP is required to work with one of the fastest growing Biotech and Med Device companies in the area. 

Responsibilities Include:
  • Execute daily tasks such as washing and sterilizing vials and filling components for use in production operations.  Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/post production.
  • Perform Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
  • Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
  • Record Activities in production batch records, and equipment logbooks as well as updating and/or authoring SOPs.
  • Review documentations and check all calculations.
  • Maintain an inventory of manufacturing supplies and order additional materials as necessary.
  • Assist in activities related to other onsite departments such as the execution of validation protocols.
  • Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
  • Occasional overtime and weekend work is required.
  • Perform tasks under minimal supervision, and within tight time lines to meet production schedule.
  • Report any unexpected observations and suggest possible explanation and resolution.
Education/Experience Needed:

BS/BA in Biology, Chemistry, or related discipline and 2-4 years experience in a GMP facility or High School Diploma and at least 5 years experience in a GMP facility.  Good interpersonal skills and attention to detail.  Previous experience working with aseptic technique and good documentation practices is required
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