Purpose and Scope 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.

Essential Duties & Responsibilities Collaborate with 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.

Knowledge, Skills & Abilities 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.

Core Values The Process Development Engineer II is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

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.

Compensation and Benefits Annual pay range $80,000 - $87,000 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.

Working Conditions Working conditions are in an office, laboratory and manufacturing environment... for full information follow application link