Senior Aseptic Operator - Phoenix AZ

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS – Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

The Senior Aseptic Operator is responsible for executing, training, and providing guidance to personnel to accomplish production activities required to successfully manufacture sterile injectable products. This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands. On a daily basis, the Senior Operator sets the example for the rest of the team by performing and ensuring the proper execution of production activities within manufacturing operations following all good manufacturing practices (GMP’s).

In addition, work will be performed in complete accordance with all standard operating procedures (SOPs), Specifications, Batch Records, regulatory expectations, and company policies. This position will require overtime, shift work, and flexibility in scheduling of “set” shift hours at times, based on production demands or extraordinary circumstances.

• Accomplish manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.
• Perform handling of hazardous materials in compliance with site, industry, local, and federal regulations.
• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
• Execute specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.
• Assure and complete detailed documentation that is a correct and accurate record. Address procedural and documentation errors expeditiously and effectively.
• Continuously update job knowledge by participating in job specialized training requirements.
• Trains and mentors (qualified trainer) department personnel to complex activities.
• Identify and champion CI (Continuous Improvement) projects.
• Performs other tasks as assigned.

• Robust functionality to operate and create in Microsoft Applications and other computer-based systems utilized in the manufacturing department (e.g., Manufacturing Execution System (MES), Human-Machine Interface (HMIs), etc.).
• Advanced proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
• Advanced written and verbal communication skills within the department and with support groups.
• Functional job specific proficiency in mathematics.
• Reading and writing proficiency in the English language.
• Practical understanding and demonstration of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
• Ability to stand up to 8 hrs./day, utilizing controlled movements.
• Advanced demonstrated skills in the setup and troubleshooting of specialized manufacturing equipment.
• Ability to execute complex activities both independently and in a team environment.

• High school diploma or equivalent required.
• Bachelor’s degree preferred.
• 4 years of relevant work experience required in a pharmaceutical environment.
• An equivalent combination of education and experience may substitute.

• The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8 hours, approximately 5 times per week.
• The incumbent may be in a standing position for at least 8 hours per day.
• The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.
• Demonstrate proficiency in the ability to gown into…