Clean Room Technician

Budd Group•Fuquay-Varina, NC

2d•$21

About The Position

This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the cleaning and sanitization program is to control contamination and to serve as a corrective action for the loss of control for excursion contamination. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment. May be required to work weekends, holidays, and overtime if needed.

Requirements

High School Diploma or equivalent
Attention to detail is required
Excellent attendance record
Must follow work instructions

Nice To Haves

Current Good Manufacturing Practices (cGMP) is a plus but not required
Good Documentation Practices (GDP) is a plus but not required
Prior experience of cleaning a GMP controlled environment is a plus but not required.
Business computer hardware and software applications

Responsibilities

Responsible for routine daily, weekly, monthly, and quarterly room sanitization in GMP process areas
Responsible for non-routine sanitization in the GMP process areas due to the environmental excursion, process requirements, or facility maintenance and construction
Responsible for verifying that the proper sanitization agent rotation is followed, proper labelling including expirations and GDP, and that the appropriate sanitization agent is used for each cleaning assignment
Responsible for completing required GMP, GDP, and ALCOA documentation to ensure records are accurately and adequately maintained contemporaneously
Responsible for mixing and disposal of sanitization solutions on a daily basis
Responsible for disposal of waste from GMP manufacturing process area waste receptacles on a regular basis
Responsible for collecting full, soiled gowning article bags on a daily basis, and replacing with new bags
Responsible for ordering general manufacturing supplies such as but not limited to clean room wipes, gloves, face masks, hairnets, shoe covers, cleaning agents, etc.
Responsible for stocking and maintaining GMP manufacturing process areas with gloves, face masks, hairnets, laundered and disposable gowning articles, and sanitizing equipment and supplies
Responsible for organization and upkeep of sanitization supply areas and general manufacturing supply areas
Responsible for organization and distribution of gowning items (laundered and disposable) within the GMP manufacturing process areas on a daily basis to ensure proper inventory levels
Responsible for participating in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering
Collaborate with Manufacturing, Facility, and Quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with GMP requirements
Participate in required training on the use of sanitization reagents and equipment
Strictly follows Standard Operating Procedures
Must pass cleanroom gowning qualification test in order to enter and sanitize the GMP filling process rooms
Strictly adheres to client protocol within controlled areas, such as airlocks.
Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE) specific to each site and area.
Performs related duties as assigned
Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
Communicating clearly and concisely, both orally and in writing in English according to GDP guidelines.
Ability to work in a team environment and independently
Establish and maintain collaborative working relationships with internal and external customers
Providing excellent customer service with both internal and external customers