Project Manager, Sterility Assurance Systems & Process Engineering

Planet Pharma; Bradley (IL); On-site; USD 145,000 - 172,000; Full time

Job summary

Planet Pharma seeks a Project Manager with sterile manufacturing and process engineering expertise to oversee compliance, process improvements, and equipment qualification initiatives. You will manage aseptic processing projects, commissioning, validation, and readiness activities, coordinating cross-functional teams to deliver high-quality results.

Required 10+ years in pharma/biotech, strong GMP knowledge, and a track record in qualification programs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• 10+ years of pharmaceutical or biotechnology experience.
• Significant experience in sterile manufacturing environments.
• Project management experience supporting technical and engineering initiatives.
• Experience with qualification and validation programs.
• Strong knowledge of GMP requirements.

Responsibilities

• Lead process-focused engineering projects from initiation through completion.
• Manage equipment implementation and qualification activities.
• Coordinate cross-functional engineering and operational teams.
• Support vendor selection, procurement, and technical reviews.
• Develop project plans, schedules, budgets, and risk mitigation strategies.
• Ensure project deliverables meet quality and compliance requirements.
• Support commissioning, qualification, and validation execution.
• Facilitate stakeholder communication and project governance.
• Drive resolution of technical and operational challenges.

Skills

Project management

GMP knowledge

Sterile manufacturing

Cross-functional coordination

Quality systems

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Job description

Location: Bradley, IL (100% Onsite)
Duration: October 2026 - December 2028
Employment Type: Contract Consultant
Consultant Compensation
Pay Rate: $105-$125/hour
Position Overview
We are seeking a Project Manager with expertise in sterile manufacturing systems and process engineering to oversee implementation of critical compliance, process improvement, and equipment qualification initiatives. This individual will manage projects involving aseptic processing technologies, sterile filtration systems, manufacturing equipment upgrades, commissioning, validation, and operational readiness activities.
Key Responsibilities

• Lead process-focused engineering projects from initiation through completion.
• Manage equipment implementation and qualification activities.
• Coordinate cross-functional engineering and operational teams.
• Support vendor selection, procurement, and technical reviews.
• Develop project plans, schedules, budgets, and risk mitigation strategies.
• Ensure project deliverables meet quality and compliance requirements.
• Support commissioning, qualification, and validation execution.
• Facilitate stakeholder communication and project governance.
• Drive resolution of technical and operational challenges.
• Maintain accurate project documentation and reporting.
  

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• 10+ years of pharmaceutical or biotechnology experience.
• Significant experience in sterile manufacturing environments.
• Project management experience supporting technical and engineering initiatives.
• Experience with qualification and validation programs.
• Strong knowledge of GMP requirements.
  

Preferred Qualifications

• Sterile filtration experience.
• Container closure integrity testing (CCIT) experience.
• Fill-finish manufacturing experience.
• Isolator technology experience.
• Sterility assurance experience.
• Aseptic processing expertise.
• Risk assessment and quality systems experience.
  

Target Backgrounds

• Process Engineering Manager
• Manufacturing Engineering Manager
• Validation Project Manager
• Technical Project Manager
• Sterility Assurance Manager
• Pharmaceutical Engineering Manager