Sterility Assurance Project Lead - 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

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