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Manufacturing Technician I/II

Dept: Manufacturing
FLSA Status: Non-exempt

Position Summary

The Manufacturing Technician is responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product with minimal direction from Supervisor.

Manufacturing Technicians responsibilities include performing environmental monitoring, cleaning and sterilizing of glassware, cleaning of clean-room suites, manufacturing preparatory activities and clean-up, assist in formulation, visual inspections, labeling and packaging. They may be aseptically qualified to perform aseptic manufacturing set-up, filtration, filling and closure of product. With sufficient Bioserv training, they may be a primary operator of complex equipment and processes, and additional tasks that are assigned by Management in compliance with QSR’s, SOP’s, and written procedures with direction from the Project Coordinator and/or Supervisor. Manufacturing Technician is responsible of completing other activities assigned by Supervisor.

Essential Duties & Responsibilities

  • Perform environmental monitoring and complete documents associated with the activity.
  • Responsible for cleaning and sterilizing of glassware and other materials that can be sterilized.
  • Perform cleaning of cleanroom suites.
  • Responsible for staging materials and equipment prior to manufacturing activities.
  • Assist in formulation of product.
  • Perform aseptic filtration, filling and crimping of product.
  • Perform visual inspection, sampling, labeling and packaging of product.
  • Identify discrepancies during manufacturing activities and notify Project Coordinator, Supervisor, and QA to ensure actions are taken in a timely manner to prevent deviations and non-conformances due to incorrect documentation.
  • Assist with other cross functional teams on an as needed basis to ensure company’s goals and objectives are met.
  • Other duties as assigned by Management.

Position Requirements:

Education Required

High school diploma or equivalent is required. College coursework in the sciences is preferred, or equivalent work experience is required.

Experienced Required

Recommended 1-2 years of experience in the pharmaceutical or related industry. Experience with both paper and electronic systems preferred. Basic word processing skills are desirable.

Specialized or Technical Knowledge, Licenses, or Certificates Needed.

Knowledge of GMPs required. Aseptic manufacturing experience is strongly preferred. Must be a team player, willing to learn, and able to work flexible hours. Occasional heavy lifting up to 50lbs, standing, sitting, controlled hand movements, repetitive motions, some pushing and pulling.

Travel Requirements

0-10% (Between San Diego Sorrento divisions not included)

Competencies: 

Planning & Organizational

  • Prepares long –term and short term plans for the development of the department based on corporate goals. Develops action plan for streamlining activities of the department and increase efficiency.
  • Must be very meticulous, well-organized and pay attention to detail.

Interpersonal

  • Excellent communication skills when communicating with management, colleagues, peers and management of other departments, third parties and regulatory agencies. Must be friendly, possess good interpersonal skills and a team player.

Communication

  • Excellent verbal and written communication skills. Capable of communicating effectively in English with all departments, management, third party contractors and auditors.

Autonomy and Independence

  • Interact with all team members as needed and capable of working independently with little supervision.

 

Physical Requirements:
Activity Never
(0%)
Occasionally
(1% – 19%)
Frequently
(20% – 79%)
Constant
(80% and above)
Visual Acuity X
Hearing X
Oral Communication X
Written Communication X
Walking X
Prolonged Standing X
Lifting (under 25 lbs.) X
Lifting (over 25 lbs.) X
SPOTLIGHT: It was a busy year for Bioserv! We manufactured 29 different products that were used for studies in 8 countries around the world.