Location: Houston,TX, USA
What We Are Looking For
The Sterile Operations Technician III is responsible for executing all processes in the production of sterile preparations, while strictly adhering to current Good Manufacturing Practices (cGMP), and department Standard Operating Procedures (SOPs).
What You Will Do
• Performs sterile manufacturing in an ISO classified cGMP environment
• Manufactures sterile preparations accurately and in compliance with batch record
• Utilizes appropriate aseptic technique when performing tasks within the clean room
• Operates all production and ancillary manufacturing equipment to deliver quality medication
• Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance with approved procedures
• Aids with sterilization of components used in the manufacturing process
• Performs manufacturing calculations and completes thorough documentation
• Prepares work area and supplies thoroughly prior to manufacturing
• Performs transfer of products to visual inspection
• Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, bubble point testing, inventory accounting, autoclaving, and LEAN manufacturing tasks
• Becomes trained and qualified in the sterile operation via internal training program
• Performs other duties and responsibilities within the department to ensure timely execution of the production schedule
• Ensures all required hygienic practices and garbing are performed per company policy
• Observes and aids in coaching new hires on sterile operations
• Is dependable with attendance and is on-time for each shift start
• Assist with special projects as needed
Who You Are
• Education: College Degree or equivalent, required
• Previous 2-3 years cGMP/USP or LEAN manufacturing experience, required
• Experience with operation of equipment and/or tools required
• Detail-oriented and self-motivated
• Work in a confined, controlled environment for extended periods of time (4 plus hours)
• Must be able to work with hazardous substances (drugs) and work with strong odors (such as peracetic acid)
• Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery
• Ability to carry out detailed written or oral instructions
• Must be able to fully gown in aseptic garb for extended periods of time
• Must pass gowning sampling within two attempts for entry into the cleanroom
• Must be able to perform rudimentary mathematical calculations as related to manufacturing processes
• Experienced with the use of a respirator, preferred
Who We Are
Wilcrest Pharma is 503B outsourcing facility dedicated to addressing critical gaps in the pharmaceutical industry. Our mission is to deliver high-quality antineoplastic medications and help mitigate drug shortages, enhancing patient care across health systems, clinics, pharmacies, and other healthcare providers.