Process Development Engineer III (6 Month Temp Position)

Tolmar Careers • Windsor, CO

30d

About The Position

Purpose and Scope Performs the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and 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. Essential Duties & Responsibilities Collaborate with formulation team to develop manufacturing processes for new products. Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new products. Interface with equipment vendors to specify equipment, request quotes and order equipment. Write protocols, reports, batch records, procedures and other controlled documentation. Perform process 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. 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.

Requirements

• Knowledge of pharmaceutical manufacturing processes and systems.
• 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.
• Five or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.

Responsibilities

• Collaborate with formulation team to develop manufacturing processes for new products.
• Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new products.
• Interface with equipment vendors to specify equipment, request quotes and order equipment.
• Write protocols, reports, batch records, procedures and other controlled documentation.
• Perform process 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.
• 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

• Link to general benefits information: 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.

What This Job Offers

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