Manufacturing GMP Cleaner

Overview

Performs and coordinates GMP cleaning and sanitization of process areas on the manufacturing floor related to the manufacturing of bulk drug substance in a multi-product facility. Responsible for cleaning and sanitization of small parts and hoses used in the manufacturing process. Works under limited supervision and follows standard operating and manufacturing procedures.

• Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations/habits and escalates appropriately.
• Maintains production areas according to predefined standards (5S).
• Prepares cleaning solutions applicable to the area.
• Cleans specified rooms on the manufacturing floor using approved cleaning solutions, wearing appropriate PPE including respirator if required.
• Performs other duties as assigned such as trash removal, floor-to-ceiling cleaning, tidying up areas (5S), cleaning of small parts and equipment, and real-time documentation of cleaning in each area.
• Maintains current online training and qualifications.
• Works in a highly regulated environment following applicable Boehringer and Boehringer Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
• Available to work according to given schedules in a 24/7 shift structure with flexibility to adapt schedules on prior notice.
• GMP room cleaning and trash removal.

• 1 or more years of experience in a cGMP regulated industry is desired.
• Physically demanding role with strong attention to detail and ability to document activities in real time.
• Moderate to high focus on execution of tasks with moderate technical complexity.
• Performs moderate proceduralized tasks and identifies process anomalies and areas for improvement.
• Strong working knowledge of fundamental manufacturing concepts; moderate technical knowledge of biologics operations is preferred.
• Ability to concentrate on detail-oriented work in a moderate technical setup with a Quality and Right-first-time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and, ideally, experience with process.
• Familiarity with cleaning chemical components and safety requirements.

• Wear proper PPE that may include a respirator to protect from cleaning agents, safety shoes, and gloves.
• Must be able to obtain full medical respiratory clearance and successfully complete a respirator fit test.
• Ability to perform repetitive motions, with potential bending and reaching overhead; ability to lift up to 40 lbs.

• High School Diploma; 1-2 years’ work experience in a GMP regulated industry is desired.

Pay Rate Range: $20-26/hr depending on experience

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.