Manufacturing Specialist - Specialty Injectables (3rd Shift)

Core Hours

Monday - Friday, 10:00 pm - 6:30 am

Purpose and Scope

The Manufacturing Specialist - Specialty Injectables serves in an advanced technical capacity, taking responsibility for the operation of complex equipment, optimizing processes, and mentoring junior staff. This role may primarily focus on either Injectables (Sterile Filling/Bulking), Bulking (Polymer), or encompass both areas.

Key Responsibilities

• Act as the technical expert for setting up and operating complex manufacturing processes, handling all aspects of equipment setup, operation, disassembly, and cleaning independently.
• Lead advanced troubleshooting efforts and resolve equipment and process issues as they arise.
• Read and interpret reports, apply basic troubleshooting skills, and collaborate with Maintenance to address issues, such as filter testing, pressure hold tests, milling, SIP/VHP, PMS, and autoclave operations.
• Take ownership of batch record documentation and corrections, including supporting deviation investigations.
• Lead initiatives focused on process optimization and continuous improvement.
• Mentor and train junior operators in advanced equipment operation and troubleshooting.
• Perform responsibilities in compliance with standard operating procedures (SOPs) and production records, with an emphasis on "Right the First Time" execution.
• Record data in notebooks or laboratory forms, accurately calculating results to support manufacturing processes.
• Work in a clean room environment, adhering to gowning requirements, which include:




• Company-provided scrubs
• Shoe covers and sterile boot covers
• Hairnets (and beard covers, as applicable)
• Tyvek coveralls
• Gloves
• Full-face masks/hoods
• Goggles
• Chemical protection PPE




• Manage the issuance of bulk materials as needed for production.
• Clean manufacturing areas to maintain a cGMP environment in accordance with Tolmar Standard Operating Procedures.
• Identify minor maintenance needs on production equipment and assist with equipment setup.
• Perform second checker duties, ensuring that all production activities are accurately documented on batch records in compliance with cGMP standards.
• Ensure product quality consistently meets approved specifications.
• Assist and support specialty injectables activities and projects as required.
• Handle hazardous raw materials and cleaning solutions in accordance with all safety procedures and policies.
• Participate in required annual hazardous waste training, including involvement in container and tank management, inspections, hazardous waste generation, and transfer, and respond to spills according to Chemical Spill Procedures.
• Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform their job duties.
• Review and maintain log books, production records, and associated documents to ensure compliance with regulatory requirements, GMPs, and Tolmar SOPs.
• Perform visual and physical checks of in-process and finished products as needed.
• Assist with the formulation of bulk materials.

Injectables Specific Responsibilities

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  • Set up and operate semi-automatic filling equipment for syringes used in both general and sterile manufacturing areas.
  • Set up and operate equipment associated with the Bulking process.
  • Assist with steam-in-place (SIP) operations on equipment used for sterile bulking processes.
  • Conduct biological sampling of general manufacturing clean room facilities.
  • Perform 100% inspections of pre-filled syringes.
  • Assist and support aseptic process development activities and projects as directed by the Specialty Injectables Manager.
  
  
  
  

Polymer Specific Responsibilities

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  • Independently perform setup, operation, disassembly, and cleaning of production bulking, milling, and packaging equipment.
  • Complete cleaning, inspection, and lubrication of all Polymer area production equipment.
  • Act as the liaison between operations and maintenance staff for maintenance activities beyond the scope of manufacturing personnel.
  • Formulate bulk materials as required.
  
  
  
  
• Perform other duties as assigned.

• Possesses advanced working knowledge of current Good Manufacturing Procedures (cGMP), demonstrating expertise in applying these standards to all relevant manufacturing operations.
• Capable of standing for extended periods (up to 8 hours or more), maintaining effectiveness and focus throughout the shift.
• Able to learn and apply aseptic techniques, as well as work efficiently in an aseptic environment.
• Demonstrates strong proficiency with basic computer software, supporting daily operational needs and documentation requirements.
• Holds advanced knowledge of Human-Machine Interface (HMI) systems, particularly for basic troubleshooting tasks.
• Understands product quality and equipment operation thoroughly, including the cause-and-effect relationships that impact product quality and equipment performance (e.g., valve setup, impact, and pressure safety for gaskets and steam).
• Possesses comprehensive knowledge of the sterile enclosed equipment train and the bulking process, ensuring safe and efficient production.
• Able to interpret technical drawings and protocols accurately, train junior operators, and ensure precise execution of tasks on the production floor.
• Maintains focus and high accuracy when handling detail-oriented and repetitive tasks, supporting quality and compliance goals.
• Exhibits excellent verbal and written communication skills, facilitating clear information exchange and effective teamwork.
• Able to follow and understand written production records and validation protocols, ensuring compliance with established procedures.
• Demonstrates understanding of basic math and writing skills, which are essential for documenting production activities in batch records and log books.
• Able to keep accurate records and perform necessary mathematical calculations, supporting operational and regulatory requirements.
• Capable of completing required documentation legibly to maintain compliance and traceability.
• Pays strong attention to detail, crucial for accurate production documentation and inspection of goods to meet specified requirements.
• Able to efficiently operate in a fast-paced manual assembly line environment, using basic production equipment as needed.
• Comfortable wearing a respirator for extended periods (up to 4 hours) while performing assigned tasks.
• Able to lift up to 40 lbs. as required by production activities.
• Able to lift arms above shoulder height repetitively throughout the shift, particularly when cleaning production areas or equipment.
• Provides support and direction to Process Development personnel within the area, contributing to team effectiveness.
• Capable of operating new production equipment with little or no prior experience, demonstrating adaptability and a willingness to learn.
• Able to achieve passing results on an internal inspection qualification for syringe inspection using semi-automated equipment for at least one syringe type.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

• Bachelor's degree in a science or engineering discipline, plus a minimum of 2 years of GMP manufacturing experience
• OR a technical diploma or Associate's degree, plus at least 4 years of GMP manufacturing experience.
• OR a high school diploma or GED, plus a minimum of 6 years of GMP manufacturing experience.
• Demonstrated competence in aseptic operations, troubleshooting, and cross-functional collaboration strongly preferred.
• Six Sigma Green Belt certification or an equivalent qualification is preferred.
• Lean Six Sigma Black or Green Belt certification may be accepted in place of one year of the required experience.

Working Conditions

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

Compensation and Benefits

• Pay: $36.00 - $40.75 per hour, depending on experience
• Shift Differential: $2.50 per hour
• Eligible for quarterly incentive bonus
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

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.