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Process Engineer

Process Engineer

TalentBridgeRochester, NY
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Job Title

Process Engineer

Location

Rochester, NY | Onsite

Compensation & Schedule

  • annual salary
  • Monday – Friday standard schedule, with occasional travel required
  • W Employment
  • Start Date : As soon as possible

Role Impact

This Process Engineer role supports pharmaceutical manufacturing operations, focusing on equipment installation, process optimization, and system validation. The engineer leads technical project execution from design through commissioning, supporting sterile and non-sterile product lines across a regulated production environment.

Key Responsibilities

  • Define and document technical specifications (URS, FS) for manufacturing and utility systems
  • Scope projects, develop RFPs, and evaluate vendor proposals
  • Manage installation, commissioning, and validation of processing equipment
  • Conduct audits, inspections, and safety reviews across new and existing systems
  • Coordinate suppliers, vendors, and internal stakeholders to meet deadlines and budgets
  • Lead issue resolution efforts and proactively escalate risks to site leadership
  • Support operator training and produce technical documentation and reports
  • Ensure project drawings, records, and compliance documentation are accurate and up to date
  • Contribute to investment studies and collaborate on cross-functional project teams

    • Minimum Qualifications

  • Bachelor’s degree in Chemical Engineering or related discipline
  • years experience in manufacturing, processing equipment, or packaging technology
  • Proficiency in CAD (AutoCAD), P&IDs, and Microsoft Office including Visio and Project
  • Ability to manage multiple stakeholders in a regulated (FDA / cGMP) environment

    • Core Tech Environment

    AutoCAD

  • Cleanroom design
  • cGMP systems
  • Equipment validation
  • FDA compliance
  • Process piping
  • Project management tools
  • Sterile packaging lines
  • Utility systems
  • Visio

    • Preferred Skills

  • Master’s degree or equivalent advanced training
  • Experience with plastic molding, solids / liquids manufacturing, or cleanroom settings
  • Familiarity with pharmaceutical commissioning and qualification protocols

    • EEO / ADA Statement

    We are an equal opportunity employer and provide reasonable accommodations upon request.

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