Process Development Engineer II

Responsibilities

• Design and implement aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial scale-up.
• Collaborate with formulation teams to develop and improve manufacturing processes for new and existing products.
• Conduct process research for the bulking, cleaning, and filling of new sterile products.
• Interface with equipment vendors to specify, quote, and order necessary equipment.
• Write protocols, reports, batch records, procedures, and other controlled documentation.
• Develop and perform process and cleaning validations, including writing validation reports.
• Provide hands-on execution of engineering studies and manufacture of clinical trial batches.
• Ensure compliance with cGMP requirements in collaboration with Quality Assurance, Validation, and Regulatory teams.
• Utilize Quality-by-Design (QbD) and Design of Experiments (DoE) to develop Risk Assessments and Critical Process Parameters (CPPs).

Requirements

• Bachelor’s degree in chemical engineering or a related scientific discipline.
• 3+ years of experience in product or process development within the pharmaceutical or biotech industry.
• Strong knowledge of aseptic processing practices and requirements for aseptic manufacturing environments.
• Thorough understanding of FDA guidelines and cGMP requirements.
• Experience with Quality-by-Design (QbD) and Design of Experiments (DoE).
• Excellent professional written and verbal communication skills.
• Ability to manage multiple projects and work both independently and as part of a team.

Benefits

• Hourly rate of $45.00 per hour.
• Please note that due to the temporary and part-time nature of this position (20 hours per week), not all benefits may apply.

About the Company

Tolmar is a pharmaceutical company dedicated to improving patient lives through innovation and excellence. We operate under core values of being people-centered, proactive, ethical, constantly improving, and accountable.