Process Engineer - Purification & Separation Engineering (PS&E)

Under general supervision, this role provides engineering support across operations, manufacturing, pilot plant, and capital project environments. Responsibilities include process optimization, troubleshooting operational issues, and applying engineering principles to system modifications, experiments, and small‑scope projects. The role requires strong analytical skills to organize, interpret, and present results for operational or engineering activities.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures; seek guidance for unusual or complex issues.
• Perform assignments with clear objectives requiring investigation of a limited number of variables.
• Initiate and complete routine technical tasks independently.
• Serve as a technical expert for equipment and systems during troubleshooting activities.
• Engage directly in daily operations when needed to meet production schedules or resolve complex issues.
• Conduct routine audits of equipment performance and regulatory compliance for systems of significant complexity.
• Collaborate with cross‑functional teams (Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, Validation) to define requirements and recommendations for system or process modifications.
• Support project managers in completing design, engineering, and construction projects within established timelines and budgets.
• Partner with consultants, architects, and engineering firms to develop standard design documentation.
• Obtain and evaluate quotes for equipment modifications or installations.
• Prepare basic project cost estimates and schedules.
• Perform additional engineering duties as assigned.

Requirements

• Master’s degree in Engineering OR
• Bachelor’s degree in Engineering + 2 years of engineering experience

Preferred Qualifications

• Working knowledge of pharmaceutical/biotech processes.
• Ability to operate specialized laboratory equipment and relevant software.
• Understanding and application of GLPs and GMPs.
• Experience in purification operations.
• Strong knowledge of chromatography and UFDF (Ultrafiltration/Diafiltration) techniques.
• Technical report writing proficiency.
• Solid understanding of validation protocol execution.
• Skills in: Personal organization
• Validation protocol
• Change management
• Equipment‑specific technical knowledge
• Analytical problem solving
• Computer literacy