Project Engineer - Technical Operations

Job Description

Job Description

Under general supervision, the Project Engineer – Technical Operations is responsible for supporting process optimization, troubleshooting operational issues, and executing small to mid-scale capital projects within biotech or pharmaceutical manufacturing environments. The role requires applying engineering principles to the design, implementation, and improvement of process systems and equipment, ensuring compliance with cGMP regulations and internal standards. This position collaborates with cross-functional teams to plan, execute, and close out projects related to equipment upgrades, facility modifications, and commissioning & qualification (C&Q) activities.

Key Responsibilities

• Provide technical solutions to moderately complex operational issues.
• Apply standard engineering methods for troubleshooting and system improvements under general supervision.
• Conduct audits on the performance and compliance of manufacturing systems and equipment.
• Collaborate with departments including Manufacturing, Process Development, QA, Maintenance, Utilities, and Validation to recommend system modifications and enhancements.
• Participate in root cause analysis and resolution of equipment or process failures.
• Work with Manufacturing to define and document user requirements for AML6 and other capital projects.
• Develop and maintain project schedules for installation, commissioning, qualification, and start-up activities.
• Coordinate with external contractors, engineering consultants, and construction teams to deliver project milestones.
• Administer all aspects of project execution, including implementation, change control, and closeout.
• Review and approve change orders, invoices, and progress reports from engineering firms and contractors.
• Prepare and present detailed project updates and status reports to site and senior leadership.
• Support project managers in delivering design and construction projects on time and within budget.
• Collaborate on the creation and review of engineering design documents and specifications.
• Evaluate quotes for equipment procurement or modification and generate cost estimates and schedules.

Technical & Professional Competencies

Preferred Personal Attributes

Requirements

Qualifications

Preferred Qualifications

Benefits