Process Engineer

Responsibilities

• Develop, implement, and optimize manufacturing packaging processes to improve efficiency, quality, and productivity
• Implement process improvement projects for aseptic filling, lyophilization, or inspection & packaging
• Develop user requirements (URS), technical specifications, and design specifications for new or upgraded equipment
• Author and execute commissioning, qualification, and validation protocols (FAT, SAT, IQ, OQ)
• Collaborate with external engineering firms and OEMs on design and feasibility assessments
• Provide technical support and training to operations and maintenance teams
• Support complex site investigations and implement CAPA plans

Requirements

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, or Biomedical) or related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry
• Knowledge of aseptic processing and packaging engineering best practices
• Ability to lead and execute engineering projects
• Understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems, and Building Management systems
• Ability to read mechanical, electrical, and P&ID drawings
• Proficiency in AutoCAD or equivalent component design software
• Proficiency in Microsoft Office Suite
• Experience with enterprise software such as JDE, Microsoft Dynamics, BPLM, Veeva, or Trackwise

Benefits

• Medical and Dental coverage
• 401(k) with company match
• Paid Time Off and Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite amenities including a workout facility and cafeteria

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.