Oregon Freeze Dry-posted 3 months ago
Albany, OR
Food Manufacturing

The Project Engineer III leads capital projects that enhance facility assets and expand life sciences processing capabilities within a CDMO environment. This role integrates project engineering with validation responsibilities, including FAT, SAT, and IQ/OQ/PQ activities, ensuring compliance with cGMP and regulatory standards. The role collaborates closely with cross-functional teams to deliver compliant, efficient, and scalable solutions that support operational excellence. Emphasis is placed on driving innovation while maintaining safety, quality, and environmental integrity.

  • Executes all aspects of capital projects as assigned, including cost estimates, scope definition, capital appropriation requests, design specifications, bidding, budget management, contractor management, installation, and start-up.
  • Builds and maintains relationships with reliable contractors, vendors, and fabricators.
  • Researches and identifies new technologies and equipment solutions to enhance operational efficiency.
  • Leads and performs equipment and process validation activities for both new and existing systems, including the creation, review, and approval of validation documentation.
  • Develops and implements validation protocols and reports to ensure compliance with cGMP, CFR, and other regulatory standards.
  • Supports and executes technology transfer activities for new products and processes, including scale-up and troubleshooting.
  • Provides technical expertise and support to R&D, manufacturing, and maintenance teams, driving improvements across laboratory, processing, and packaging systems.
  • Ensures all work complies with applicable local, state, and federal codes and regulations, including OSHA, USDA, FDA, UBC, SQF, and ISO requirements.
  • Utilizes asset management software to input new assets, maintain accurate records, analyze data, and reference historical information to guide project decisions.
  • Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, or Biomedical) or closely related technical field is required.
  • Minimum of 6 years of project engineering experience in the life sciences industry, with at least 3 years focused on validation activities.
  • Proven success in scoping, managing, and delivering capital projects within the life sciences sector.
  • Extensive experience integrating new products and projects into existing operations, ensuring seamless transitions and optimal outcomes.
  • Advanced proficiency in CAD software for design and technical documentation.
  • Exceptional ability to design, implement, and optimize processes and equipment in a manufacturing environment.
  • Excellent organizational, interpersonal, and problem-solving skills, with the ability to thrive in a fast-paced, dynamic setting.
  • Self-motivated and able to work independently while collaborating effectively across teams.
  • Commitment to embodying and promoting OFD's cultural values in daily work.
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