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Process Development Engineer II
at TOLMAR Inc.
Purpose and Scope
Assists with the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and manufacturing scale-up. Provides support in developing and recommending new process technologies to achieve improved product quality and cost effectiveness.
Essential Duties & Responsibilities
- Work with formulation team to develop manufacturing processes for new products.
- Help make process design decisions, provide input and recommendations.
- Perform scale-up activities to increase batch size from laboratory to clinical scale, and from clinical to commercial scale.
- Write protocols, reports, SOPs, user requirement specifications, laboratory notebook studies, and other controlled documents.
- Help execute process validation protocols and write validation reports.
- Interface with equipment vendors to specify equipment, request quotes and order equipment.
- Design and execute process development studies and experiments to understand and improve processes.
- Develop cleaning processes and perform cleaning validation.
- Coordinate activities for production of clinical batches, “hands on” execution of development and clinical batches.
- Train manufacturing personnel in technical manufacturing processes.
- Experience of successful interfacing with Formulation Development, Regulatory, Facilities, Manufacturing, Validation, Quality and various departments for product development.
- 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 CP 030-0202 Chemical Spill Response.
- Perform other related duties as assigned.
Knowledge, Skills & Abilities
- Knowledge of pharmaceutical process development, scale-up and validation.
- Understanding of cGMP requirements to produce the documentation necessary for manufacturing development batches within a GMP environment.
- Mechanical aptitude and ability to operate equipment.
- Knowledge of pharmaceutical manufacturing operations and specialty injectable products is desirable, but not required.
- Effective technical writing skills (batch records, protocols, etc.)
- Must be able to work in a fast-paced, changing work environment, possess good time management skills, and exhibit personal responsibility.
- Effective interpersonal communication skills.
- Ability to analyze complex problems and implement creative solutions.
- Ability to learn new technology/new products quickly.
- Ability to work independently, as well as cooperatively on a team.
- Ability to manage multiple projects and prioritize/reprioritize work.
- Positive attitude and willingness to perform labor-intensive work when necessary.
- 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 of Science in Chemical Engineering or other Engineering discipline. Degrees in other scientific discipline may be considered.
- Three or more years’ experience in product and/or process development in the Pharmaceutical/Biotech industry.
- Working conditions are in an office, laboratory and pharmaceutical 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.