Critical Environment Operator I

Location: Miami, OK – Single Use Division

About the role

The Band I Clean Room Operator supports production operations within a controlled Critical Environment area. This entry-level role performs routine manufacturing, cleaning, packaging, and documentation tasks in accordance with established Standard Operating Procedures (SOPs), Work Instructions (WOIs), Job Safety Analyses (JSAs), and Plant Safety Rules. The role requires attention to detail, willingness to learn new methodologies, and adherence to safety, quality, and productivity standards.

Responsibilities

• Perform basic operation of equipment associated with: WIFI Wash, Drying, Depyrogenation (Depyro).
• Operate sealers and package materials per established procedures.
• Pull product samples and maintain required archive samples.
• Complete all required production paperwork accurately and in real time.
• Support processes and procedures within a Critical Environment area.
• Perform tasks as directed by supervision or team leadership.
• Read, comprehend, and follow SOPs, WOIs, JSAs, and Plant Safety Rules.
• Maintain compliance with GMP and site quality requirements.
• Participate in event recognition and escalation processes as needed.
• Maintain area cleanliness and certification as an area cleaner.
• Demonstrate understanding of operational KPIs and performance tracking.
• Support and follow 7S principles for workplace organization.
• Manage time effectively to meet production timelines and demonstrated performance standards.
• Exhibit flexibility in production scheduling to meet customer expectations and facility needs.
• Work collaboratively with team members on a daily basis.
• Accept and apply constructive feedback.
• Demonstrate a willingness to learn new processes and methodologies.

Requirements

• High School Diploma or equivalent required.
• Ability to read, understand, and retain procedural documentation.
• Basic mechanical aptitude and ability to operate production equipment.
• Minimum of 6 months of experience in manufacturing or production environment preferred.
• Ability to comprehend and follow written and verbal instructions.
• Effective time management skills.
• Strong attention to detail and documentation accuracy.
• Ability to work in a controlled/critical environment.
• Flexibility to support changing production demands.
• No travel required.

Environmental Conditions

• Able to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Loud noises (equipment/machinery).
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Standing for full shift.
• Strong odors (chemical, lubricants, biological products, etc.).

Schedule

Third Shift (Nights) – Monday through Thursday, 8:00 pm to 6:00 am.

Benefits

• Annual performance-based bonus.
• Annual merit performance-based increase.
• Medical, Dental, & Vision benefits – effective Day 1.
• Paid Time Off & Designated Paid Holidays.
• Retirement Savings Plan.
• Tuition Reimbursement.
• Employee Referral Bonus.
• Career Advancement Opportunities.