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.
The Process Development Engineer III 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.
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 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.