Process Engineer Associate
Under the direction of Process Engineering team leaders, the Process Engineer will lead tech transfer projects from client or small scale to manufacturing/large scale in a manner that meets safety, quality, and operational performance expectations. The key function of this role will be to deliver effective, safe and efficient manufacturing processes for parenteral drug products.
Position Duties and Responsibilities
• Layout manufacturing process flow for parenteral drug products based on tech transfer information.
• Identify and order materials required to perform development and manufacturing.
• Identify tooling and equipment required to perform development and manufacturing.
• Develop and execute study protocols to evaluate manufacturing processes and write associated reports.
• Develop and execute batch records defining bill of materials and manufacturing processes.
• Develop SOPs for equipment operations.
• Design and execute performance qualification of instruments.
• Identify technical issues and provide necessary solutions to determine root cause.
• Accurately document and record necessary data and reports with appropriate conclusions.
• Complete quality events such as deviation with sound judgement and scientific principal.
• Maintain knowledge of equipment and manufacturing technology changes and core process technologies.
Competencies
• Solid working knowledge in the application of engineering principles, scientific analysis.
• Can perform routine and complex work instructions under general supervision.
• Can perform routine problem solving, may refer complex problems to team leader.
• Calculation, data analysis, statistics and applied mathematics.
• Project management.
• Mechanical aptitude
• Microsoft Office, Visio or other related software.
• Excellent writing skills.
• Attention to detail.
• Written and oral communication skills
Education and Experience
• Process Engineer Associate: BS/MS in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science with 0+ years industry experience.
• Process Engineer: BS/MS in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science plus at least one year industry experience.
• Level to be determined based on qualifications relevant to the role.
Physical Requirements
• Ability to meet gowning requirements.
• Ability to remain stationary for prolonged periods of time, ability to lift up to 50 lbs. periodically.
• Satisfactory audio-visual acuity and the ability to communicate.
• Gross and fine motor skills to manipulate instruments.