Project Engineer; Biotech Focus

The

Purpose:

Responsible for supporting projects for implementation of manufacturing projects within a GMP bioproduction facility, supporting the project management team with capital & operational excellence projects. Develop ideas and improvements for the production process and equipment. Participate in and drive production related projects and improvements to support optimizations, capacity improvements, and complex investigations across Departments. Reports into the Project Engineering team; works cross-functionally across the site and with external vendors/contractors as needed.

Onsite 5 days/week at the West Lebanon, NH bioproduction facility.

• Lead process and equipment troubleshooting to support deviations and corrective actions
• Ensure systems/processes are verified and kept in a validated state per FDA, EU, and NN requirements
• Develop and implement procedural or automation improvement changes
• Participate in design and hazard reviews for plant expansions/process changes; serve as technical point of contact/user representative for contractors (design, fabrication, installation, validation)
• Plan/execute activities compliantly to ensure on-time delivery
• Participate in cross-functional teams for root cause and corrective actions in investigations
• Write/review protocols, summary and trend reports, and validation/verification documentation
• Coordinate scheduling of improvements and critical production activities (including vendors)
• Initiate/manage projects: scope, justification, risk assessments, cost estimates, purchase order requisitions, and payment schedule control
• Supervise contractors/interns: mentoring, performance reviews, project/support advice, troubleshooting
  
  Participate in on-call rotations (weekends/non-business hours)
• Perform duties compliantly and ethically

• Bachelor’s degree in engineering or related discipline required
• Master’s degree preferred
• 5 years related experience with Bachelor’s required; 3 years preferred with Master’s
• Medium/large pharmaceutical or biotechnology process experience preferred

• Knowledge of automation, GMPs, compliance and regulatory requirements essential
• Excellent communication; ability to work in a high-paced team environment
• On-call availability; respond within 60 minutes