The Process Technician II is responsible for manufacturing clinical and commercial products in compliance with regulatory requirements, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).

Duties / Responsibilities may include:

• Reading, understanding, and strictly following all written policies such as SOPs, batch production records, safety procedures, and Safety Data Sheets (SDS) to support production efforts.
• Writing legibly and recording data in accordance with Good Documentation Practices (GDP).
• Completing and displaying competency for required training.
• Providing lab support for transfer of processes and manufacturing activities.
• Weighing, measuring, and checking raw materials accurately to ensure batches manufactured contain proper ingredients and quantities.
• Operating, cleaning, maintaining, assembling, and troubleshooting production equipment safely according to SOPs.
• Maintaining a clean room environment to comply with regulatory requirements, current good manufacturing practices (cGMPs) and standard operating procedures (SOPs).
• Helping validate processes and qualify equipment that are directly related to production, filtration, cleaning and sterilization.
• Learning to run equipment through review and application of SOPs.
• Following safety procedures strictly including use of personal protective equipment (PPE) and HazMat procedures, for the movement of raw materials used in chemical processes.
• Working under direct supervision performing tasks that are routine to semi-routine in nature.
• Supporting investigations and revising / reviewing SOPs.
• Troubleshooting and offering ideas on corrective actions / preventive actions (CAPAs) and improvements.
• Interacting with other departments to share information.
• Performing other duties as assigned.

Education / Experience

A High School diploma (or equivalent) is required. Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering or other science related program preferred.  A minimum of 2 years’ related experience is required. 

Additional skills needed:

• Prior experience with safety procedures.
• Solid written and oral communication skills.
• Ability to work independently with minimal supervision.
• Experience operating manufacturing or laboratory equipment is required.
• Strong Mechanical aptitude, attention to detail, ability to perform routine adjustments on standard manufacturing equipment is required.
• Computer skills in Microsoft Office: Excel, Word, PowerPoint.
• Basic math skills (multiplication, division, ratios, and percentages).
• Familiarity with the metric systems and conversion methods.
• Ability to multi-task, work in an organized manner, and possess trouble-shooting skills.

 Physical and other requirements:

This position requires the ability to work 12 hour shifts.  Must be able to lift 25 lbs. Must be able to stand for long periods of time. Must be detail oriented and able to follow written procedures. Employee may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come in to contact with chemicals or pharmaceutical agents. Employees must be able to wear a respiratory protection (filtering face piece, face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function. Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function. Employees must be able to accurately detect color and have 20/20 vision (with/without corrective lenses). Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.

Huntsville, AL site only:  Employee must be able to pass drug screening for employment consideration.