Process Development Engineer II - Part-time 20 hours

Tolmar Careers • Windsor, CO

2d • Hybrid

About The Position

Performs the design and implementation of aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial manufacturing scale-up. Provides support for existing commercial products/processes when needed. Develops and recommends new process technologies to achieve improved product quality and cost effectiveness.

Requirements

• Knowledge of pharmaceutical manufacturing processes and systems.
• Experience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.
• Knowledge of FDA guidelines and cGMP requirements.
• Excellent professional written and verbal communication and interpersonal skills.
• High attention to detail and sense of personal responsibility.
• Ability to manage multiple projects and prioritize/reprioritize work.
• Ability to work independently with minimal supervision as well as cooperatively on a team.
• Excellent ability to analyze complex development problems and provide creative solutions.
• Bachelor’s degree in chemical engineering or other scientific discipline plus equivalent engineering experience.
• Three or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.

Responsibilities

• Collaborate with the formulation team to develop and improve manufacturing processes for new and existing products.
• Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.
• Interface with equipment vendors to specify equipment, request quotes and order equipment.
• Write protocols, reports, batch records, procedures, and other controlled documentation.
• Develop and perform process validation and write validation reports.
• Develop cleaning processes and perform cleaning validation.
• Provide hands-on execution of engineering studies and manufacture of clinical trial batches.
• Understand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.
• Experience with Quality-by-Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).
• Provide technical training to manufacturing employees.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage.
• Respond to spills per the Chemical Spill Procedures.
• Perform various other duties as assigned.

Benefits

• Hourly rate: $45.00 hr
• Benefits information: https://www.tolmar.com/careers/employee-benefits
• Please note that due to the temporary and part-time nature of the position, not all benefits may apply.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level