Manufacturing Operator II (Aseptic)

ROIS; Phoenix (AZ); On-site; USD 34,000 - 48,000; Full time

Job summary

ROIS is seeking a Manufacturing Operator II (Aseptic) in Phoenix, AZ to manufacture sterile injectable products. The role requires adherence to GMPs, proper documentation, and teamwork to support production goals.

The operator will operate and troubleshoot specialized equipment, train teammates, and participate in continuous improvement initiatives, with overtime and shift flexibility as needed.

Qualifications

• Minimum of 2 years of relevant manufacturing experience in pharma/regulated environments.
• Knowledge of GMPs and regulated manufacturing environments.
• Ability to read, write, and communicate in English.
• Experience with MES, HMIs, and related manufacturing software.

Responsibilities

• Execute manufacturing activities according to established procedures, GMP requirements, batch records, and regulatory standards.
• Operate, set up, monitor, clean, and troubleshoot equipment used in sterile injectable production.
• Ensure availability of materials and resources to meet schedules and production goals.
• Handle hazardous materials safely in compliance with regulations.
• Complete production documentation accurately and audit-ready.

Skills

Attention to detail

Team collaboration

English communication

Problem solving

Education

High school diploma or equivalent

Bachelor's degree (preferred)

Tools

MES

HMIs

Microsoft Office

Job description

Job Title: Manufacturing Operator II (Aseptic)

Location: Phoenix, AZ

Pay: $25.00 - $35.09/hourly*Depending on experience* + 15% shift differential for overnight shift only

• 2:00pm-12:30am
• 8:00pm-6:30am

Position Summary

The Manufacturing Operator II is responsible for manufacturing sterile injectable pharmaceutical products while ensuring compliance with Good Manufacturing Practices (GMPs), standard operating procedures, batch records, and company policies. This role supports production operations by operating specialized equipment, maintaining accurate documentation, training team members, and contributing to continuous improvement initiatives. The position may require overtime, shift work, and schedule flexibility based on production needs.

Responsibilities

• Execute manufacturing activities according to established procedures, GMP requirements, batch records, and regulatory standards.
• Operate, set up, monitor, clean, and troubleshoot specialized manufacturing equipment used in the production of sterile injectable products.
• Ensure equipment, materials, and production resources are available to meet manufacturing schedules and production goals.
• Handle hazardous materials safely and in compliance with company, industry, local, state, and federal regulations.
• Complete production documentation accurately and promptly, ensuring records are complete, compliant, and audit-ready.
• Identify, address, and correct documentation or procedural discrepancies in a timely manner.
• Train, mentor, and support team members on manufacturing processes and operational procedures.
• Serve as a positive role model by demonstrating safe work practices, teamwork, accountability, and attention to detail.
• Participate in and support continuous improvement initiatives to enhance safety, quality, efficiency, and productivity.
• Collaborate effectively with manufacturing, quality, maintenance, and other cross-functional teams.
• Maintain compliance with all company policies, procedures, and regulatory requirements.
• Perform other duties as assigned.

Qualifications

• High school diploma or equivalent required; Bachelor's degree preferred.
• Minimum of 2 years of relevant manufacturing experience, preferably in a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Experience operating manufacturing equipment in a production setting.
• Working knowledge of Good Manufacturing Practices (GMPs) and regulated manufacturing environments.
• Proficiency with Microsoft Office and manufacturing-related computer systems, including Manufacturing Execution Systems (MES), Human-Machine Interfaces (HMIs), or similar platforms.
• Ability to read, write, and communicate effectively in English.
• Strong mathematical, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a team environment.
• Ability to train and mentor other employees.
• Understanding of sterile manufacturing processes and equipment operation preferred.
• Ability to identify process improvements and participate in continuous improvement projects.
• Ability to stand, walk, push, pull, reach, and lift more than 20 pounds throughout the workday.
• Ability to work in controlled manufacturing environments and meet gowning requirements.
• Ability to work safely around pharmaceutical products, chemicals, and other hazardous materials.
• Must be able to meet applicable medical, respiratory, and vision requirements based on assigned manufacturing area responsibilities.
• Ability to work overtime, alternate shifts, and flexible schedules as business needs require.