Lead Operator - 1st Shift

About the role

This Clean Room Manufacturing Lead Operator role involves processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. You will perform these tasks meticulously to ensure product quality, and be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment in ISO Class 5 or ISO Class 7 areas while adhering to Clean Room gowning protocols. All operations must comply with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements. The role emphasizes teamwork, daily achievements, and maintaining high-quality standards in production processes.

Responsibilities

People

• Allocate resources to meet daily schedule needs and support plan development and execution
• Partner with area management to identify overtime needs in advance
• Communicate with support groups on daily processing needs
• Provide feedback to department management on operator and process performance
• Interface with support departments to establish clear/consistent manufacturing objectives and needs

Process

• Perform all requirements of a Manufacturing Operator
• Provide daily oversight of medical manufacturing operations
• Actively engage in all areas of the manufacturing process
• Identify and resolve training gaps (process, performance, paperwork) through the execution of a training plan
• Own operator training for all new Chemical Operators
• Lead troubleshooting initiatives to minimize equipment/process downtime
• Identify equipment deficiencies and observe operator performance in manufacturing
• Support investigations as a subject matter expert
• Maintain process and component inventories
• Support time management around start/stop, breaks, and timely completion of tasks

Paperwork

• Obtain batch records in advance for associated manufacturing operations to prevent delays
• Document manufacturing activities in real time and perform daily in-process checks of paperwork
• Supply and receive paperwork from support groups when necessary to maintain manufacturing operations
• Provide comments in batch records, including non-conformance references or other clarifications
• Perform daily, in-process reviews of batch records to support good documentation practices
• Develop, redline, and/or review associated manufacturing documentation

Requirements

• High School diploma or equivalent; degree related to science preferred
• 3-5 years of chemical processing experience or batch mixing in a manufacturing environment in the Medical Device or Pharmaceutical industry
• Basic computer skills for email and data entry
• Must read, write, and speak in English, and communicate clearly and concisely
• Fundamental understanding of mathematics and chemistry
• Able to participate in a team-oriented environment and assist/train others
• Able to work independently with minimal supervision
• Understand product flow and the impact of chemical processes
• Able to work overtime

Tools and Equipment Used

• Lyophilizers
• Homogenizers
• Tornado Mill
• Vacuum pump
• pH meters
• Thermometers
• Balances (scales)
• Water bath circulators
• Humidity cabinet
• Centrifuge
• Blenders
• Air gun
• Filamatic filling machines
• Drop indicator
• Scalpels
• Pouch sealers
• Honeywell temperature recorders

Physical Requirements

• Ability to gown to ISO Class 5 and ISO Class 7 Clean Room standards
• Vision correctable to 20/25 to detect defects in product/materials
• Visual acuity adequate for quality reclassification
• Normal color perception

The physical requirements include motor/physical abilities and skills necessary to undertake the essential duties and responsibilities of the position. Reasonable accommodations may be made to empower individuals with disabilities.

Adverse Working Conditions

The role may involve exposure to hazardous and biohazardous materials, including flammable and corrosive liquids, compressed gases, and medical wastes, in a general plant environment.

Pay

Hourly pay range: $26.21 - $35.38 USD. Individual pay is determined by job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity, or other variable compensation.

Schedule

Monday to Thursday, 6:00 AM to 4:30 PM.

Benefits

• Medical, dental, and vision insurance
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))