Requisition Number: PROCE03301
Purpose and Scope
Assists with the design and implementation of aseptic manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and commercial manufacturing scale-up.
Essential Duties & Responsibilities
- Assist other Process Development Engineers as needed to refine batch records, implementing changes when necessary to address manufacturing considerations including processing, manufacturability and scale-up.
- Understand and improve process and equipment by working with formulation scientists, other engineers, and manufacturing personnel.
- Assist with lab studies and scale up evaluations.
- Help identify new equipment and components and solicit prices and quotes from vendors.
- Update procedures and other controlled documents.
- Help execute development batches, cleaning processes, and oversee execution of validation protocols.
- Assist and train manufacturing personnel in technical manufacturing processes.
- Help write numerous documents, protocols, specifications, reports, procedures, equipment qualification protocols, etc.
- 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 other related duties as assigned.
Knowledge, Skills & Abilities
- Knowledge of FDA guidelines and cGMP Procedures.
- Knowledge of aseptic processing
- Understanding of cGMP requirements to produce the documentation necessary for manufacturing development batches within a GMP environment.
- Knowledge of pharmaceutical process development, scale-up and validation.
- Knowledge of chemistry, engineering principles, and pharmaceutical industry.
- Familiarity with computer-aided design and other computer software (Word, Excel, Visio, for example).
- Good documentation practice and technical writing ability.
- Effective written and oral communication skills.
- Ability to analyze complex development problems, propose and implement creative solutions.
- Ability to work independently with minimal supervision as well as cooperatively on a team.
- Must be able to work in a fast-paced, changing work environment, possess good time management skills and exhibit personal responsibility.
- The Process Development Engineer I 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
- B.S. in an engineering discipline, chemical or mechanical engineering preferred. Degrees in other scientific discipline may be considered.
- One or more years’ experience in an engineering environment within the Pharmaceutical/Biotech industry.
- 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
- Pay Rate: $20-$25 per hour
- Benefits information: https://www.tolmar.com/careers/employee-benefits