Tolmar, Inc. is hiring a Process Development Engineer to design and implement manufacturing processes, instrumentation, and equipment from the laboratory through pilot plant and full-scale manufacturing. You will support existing commercial products and develop new process technologies to improve product quality and cost-effectiveness.
What You'll Do
- Collaborate with the formulation team to develop manufacturing processes for new products.
- Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling.
- Interface with equipment vendors to specify equipment, request quotes, and place orders.
- Write protocols, reports, batch records, procedures, and other controlled documentation.
- Perform process validation.
- Provide hands-on execution of engineering studies and manufacture 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 and respond to spills per Chemical Spill Procedures.
- Perform various other duties as assigned.
What We're Looking For
- Bachelor's Degree in Chemical Engineering or another scientific discipline plus equivalent engineering experience.
- Five or more years of experience in Product and/or Process Development within the Pharmaceutical/Biotech industry.
- 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 a strong sense of personal responsibility.
- Ability to manage multiple projects and prioritize/re-prioritize 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.
Team & Environment
We center on people, are proactive & agile, act ethically, constantly improve, and are accountable.
Benefits & Compensation
- Hourly rate of $55.00 per hour, dependent on experience.
Work Mode
This is an onsite position.
