Process Development Engineer III (6 Month Temp 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.

Knowledge, Skills & Abilities

• 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.

Core Values

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

• Center on People: We commit to support the wellbeing of our patients and treat 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 with an enterprisewide mindset that lifts the whole organization.
• 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risktaking that drives better ways of working.
• 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.

Education & Experience

• 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.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment.
• Work may require occasional weekend and/or evening work.
• Work may require lifting objects up to 25 lbs. and use of a respirator.

Compensation and Benefits

• Hourly rate $55.00 per hour depending experience
• 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. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.