Senior Project Manager – Process Engineering / CQV

Job Overview

We are seeking an experienced Senior Project Manager with a strong background in Process Engineering and CQV to support capital and operational projects at a leading biopharmaceutical facility in Bend, Oregon. This role will be responsible for managing projects related to process systems, equipment, and facility improvements within a GMP-regulated environment.

Key Responsibilities

• Lead end-to-end execution of process engineering, equipment, and facility-related projects.
• Manage project schedules, budgets, risks, resources, and deliverables across multiple workstreams.
• Coordinate with cross-functional teams including Process Engineering, Validation, Quality, Manufacturing, and Operations.
• Oversee commissioning, qualification, and validation (CQV) activities including IQ/OQ/PQ.
• Ensure compliance with GMP, FDA, and other regulatory requirements.
• Support process improvements, technology transfers, scale-up, and operational readiness initiatives.
• Interface with vendors, contractors, and internal stakeholders to drive project success.
• Provide regular project status updates, metrics, and reporting to senior leadership.

Required Qualifications

• 10+ years of project management experience within life sciences industries.
• Strong background in Process Engineering, CQV, or a combination of both.
• Proven experience managing projects in biotech, pharmaceutical, or biologics manufacturing environments.
• Solid understanding of manufacturing equipment, utilities, and process systems.
• Hands-on experience working in GMP-regulated environments.
• Excellent leadership, communication, and organizational skills with strong technical acumen.

Preferred Qualifications

• PMP certification preferred.
• Hands-on experience with CQV execution and oversight (IQ/OQ/PQ).
• Experience with process validation, PPQ, or technology transfer projects.
• Familiarity with biologics manufacturing processes including upstream and downstream operations.