Manufacturing Operator II - Specialty Injectables

Purpose and Scope

The Manufacturing Operator II is responsible for executing manufacturing processes with a focus on Good Manufacturing Practice (GMP) compliance, aseptic proficiency, and technical proficiency. This role demonstrates growing technical expertise, reliability in documentation, and begins mentoring junior staff.

Key Responsibilities

• Maintain high standard of GMP
• Accurately execute and document batch record activities in compliance with GMP and SOP requirements
• Properly perform job duties ensuring all production activities and cleaning are correctly performed on batch records in accordance with cGMP standards
• Demonstrate reliability and accuracy in all documentation and compliance activities
• Comply with safety protocols and clean room gowning requirements
• Respond to spills per the Chemical Spill Procedures
• Maintain clean room standards and ensure adherence to safety protocols
• Perform visual and physical checks of in-process and finished product
• Operate, troubleshoot, and maintain complex production equipment
• Participate in continuous improvement and deviation investigations
• Support the escalation and triage of atypical events with Quality, Maintenance, and MFG leadership

Technical Expert

• Troubleshoot equipment and process issues with increasing independence and direct supervision
• Competently set up, operate, disassemble, and clean complex production equipment
• Understand and execute accurately technical drawings on the floor
• Read and understand reports and support Maintenance as needed to resolve issues
• Master of equipment ownership and process troubleshooting

Injectables Specific Responsibilities

• Correctly perform aseptic interventions as per procedure
• Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas
• Set up and operate equipment connected with Bulking process
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes
• Perform biological sampling of general manufacturing clean room facilities
• Perform 100% inspections of pre-filled syringes

Polymer Specific Responsibilities

• Perform the setup/operation/disassembly and cleaning of production bulking, milling and packaging equipment independent of maintenance personnel oversight
• Complete cleaning, inspection and lubrication tasks on all Polymer area production equipment
• Act as liaison between operations and maintenance staff when maintenance requirements are beyond the capability/scope of manufacturing personnel
• Formulate bulk materials
• Perform other duties as required

Knowledge, Skills & Abilities

• Strong working knowledge of current Good Manufacturing Procedures (cGMP)
• Ability to stand for extended periods of time (up to 8 hours or more)
• Strong knowledge of basic computer software Windows, Electronic Batch Records and other automated equipment
• Excellent verbal and written communication skills
• Interact with peers and members of other departments in team settings in a professional manner
• Able to maintain focus on detail-oriented, repetitive tasks
• Able to document production activities in batch records and/or logbooks
• Able to perform mathematical calculations
• Able to legibly complete required documentation
• Able to provide support as well as directions to Process Development personnel in the area
• Able to operate new production equipment with little to no previous experience
• Able to lead others in proper aseptic technique and work in an aseptic environment
• Able to receive passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type

Core Values

• Center on People
• Are Proactive & Agile
• Act Ethically
• Constantly Improve
• Are Accountable

Education & Experience

• High school diploma or equivalent required
• STEM Bachelor’s Degree required, or equivalent combination of education and experience as follows:
• Non-STEM degree and 1 or more years of technical /manufacturing experience
• Technical Associate’s Degree and 2 or more years of technical/manufacturing experience
• High School Diploma or GED and 4 or more years of technical/manufacturing experience
• Six Sigma Green Belt or equivalent preferred
• Black Belt or Green Belt certification in Lean Six Sigma or equivalent will be accepted in lieu of one year of experience

Working Conditions

• Shift work in a manufacturing and warehouse environment
• May require overtime and occasional weekend work

Compensation And Benefits

Pay: $29.00 - $32.00 per hour depending on experience
Shift Differential
B Shift: $2.50 per hour
D Shift: $4.50 per hour
Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar is an Equal Opportunity Employer

We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.