Project Engineer II: GMP Capital Projects

Actalent; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

Actalent is seeking a Project Engineer II for a GMP-regulated pharmaceutical manufacturing environment. You will lead capital projects from concept through startup, coordinating cross-functional teams to deliver safe, compliant, and reliable equipment, processes, and systems.

Responsibilities include scope, schedule, budget management, vendor oversight, design reviews, and validation activities to ensure readiness for regulatory inspections. Strong problem-solving and leadership are essential.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 3–6 years of experience executing capital projects in manufacturing environments.
• 5+ years of experience in a regulated environment (pharma/medical device).
• Proven ability to lead capital projects from concept through commissioning and handover.
• Experience defining scope, schedule, budget, and resources with minimal supervision.
• Strong project management skills with risk mitigation and issue resolution.
• Hands-on experience with manufacturing processes, installation, commissioning, and troubleshooting.
• Knowledge of GMP requirements and FDA quality systems.
• Experience with validation and qualification activities (IQ/OQ/PQ).

Responsibilities

• Lead capital projects from concept through commissioning, qualification, and handover.
• Define and manage scope, schedule, budget, and resources to meet objectives.
• Manage vendors, contractors, and procurement to ensure timely delivery.
• Identify and mitigate project risks and drive issue resolution.
• Lead design reviews and approve engineering deliverables for safety and compliance.
• Oversee installation, commissioning, startup, and troubleshooting of equipment.
• Provide technical guidance on process optimization and system improvements.
• Ensure all projects comply with FDA, GMP, and internal quality systems.
• Own change control activities and validation efforts (IQ/OQ/PQ).
• Collaborate across Manufacturing, Quality, Validation, Maintenance, and EHS teams.

Skills

Project management

Cross-functional collaboration

Regulatory compliance

Risk management

Equipment installation

ValidationIQOQPQ

Education

Engineering degree

Job description

Actalent is seeking a Project Engineer II for a GMP-regulated pharmaceutical manufacturing environment. You will lead capital projects from concept through startup, coordinating cross-functional teams to deliver safe, compliant, and reliable equipment, processes, and systems.

Responsibilities include scope, schedule, budget management, vendor oversight, design reviews, and validation activities to ensure readiness for regulatory inspections. Strong problem-solving and leadership are essential.