Project Manager, Sterility Assurance Systems & Process Engineering

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

Job summary

Planet Pharma is seeking a Project Manager for Sterility Assurance Systems & Process Engineering to oversee sterile manufacturing projects in Bradley, IL. The role focuses on compliance, process improvements, and equipment qualification across aseptic processing technologies and qualification activities.

The position requires a Bachelor’s degree in engineering or life sciences and 10+ years in pharmaceutical/biotech environments, with strong GMP knowledge and extensive project management

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.
• Maintain accurate project documentation and reporting.

Skills

Project management

GMP knowledge

Sterile manufacturing

Qualification & validation

Cross-functional leadership

Education

Bachelor’s degree in Engineering/Life Sciences

Job description

Project Manager, Sterility Assurance Systems & Process Engineering

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