Biotechnology Manufacturing Specialist

2 weeks ago


Portsmouth, Virginia, United States Sunrise Systems Full time
Job Title: Biotechnology Manufacturing Specialist

Position Type: Hourly Contract Role (W2 Only)


Note:

This position is part of the Cell and Gene division.

Shifts available: 12-hour shifts

Job Overview

The Manufacturing Specialist is accountable for the production of therapeutic proteins (Active Pharmaceutical Ingredients) under current Good Manufacturing Practices (cGMP). Entry-level associates are expected to implement process protocols, adhere to documented procedures (Standard Operating Procedures), oversee equipment and operational processes, perform fundamental laboratory tasks such as pH and conductivity measurements, sampling, and conduct routine cleaning tasks to uphold facility and equipment standards.

Key Responsibilities
  • 40% Set up and operate machinery while overseeing production workflows, including clean-in-place (CIP) and steam-in-place (SIP) processes, documenting production activities in both written and electronic formats in compliance with good manufacturing practices (GMP) and good documentation practices (GDP), and reviewing documentation as necessary.
  • 20% Achieve qualification for all designated tasks and maintain an individual training program.
  • 10% Conduct basic laboratory tasks, including monitoring pH, conductivity, and testing product samples.
  • 10% Manage material handling, transferring raw materials and chemicals within production areas.
  • 10% Ensure the upkeep of the facility and equipment through regular cleaning and sanitization, supporting 6S initiatives.
  • 10% Perform administrative duties such as attending shift exchanges, participating in meetings, managing emails, engaging in projects, and executing other assigned responsibilities.
Qualifications
  • Minimum of a High School Diploma or Equivalent; AS/BS preferred.
  • Preferred educational background in a science-related field.
  • 0-3 years of experience; prior experience in a manufacturing environment is advantageous.
  • Demonstrated logical reasoning and decision-making capabilities, along with critical thinking skills.


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