What are the responsibilities and job description for the Senior Project Manager(CQV) position at Intellectt Inc?
Job Title: Senior Project Manager – Process Engineering / CQV
Location: Bend, Oregon (On-site)
Duration: 12 Months
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.