Senior Process Engineer - Remote

Overview

We are seeking a Project Engineer with extensive experience in equipment for manufacturing and packaging. This role involves leveraging expertise in project management and process improvements to drive compliance, efficiency, and innovation.

In Short

• Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
• Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation.
• Lead and implement change management strategies for manufacturing and packaging.
• Manage and review equipment change requests.
• Collaborate with regulatory, quality, and manufacturing teams.
• Plan, execute, and oversee manufacturing and packaging projects.
• Identify project risks and implement risk mitigation strategies.
• Drive continuous improvement initiatives.
• Provide technical expertise and troubleshooting support.
• Support product launches and regulatory requirements.

Requirements

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.
• 7-11 years of experience in pharmaceutical manufacturing and packaging.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines.
• Proficiency with quality systems and compliance.
• Excellent communication skills.
• Strong project management skills.
• Detail-oriented with strong analytical capabilities.
• Ability to work in a fast-paced environment.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program.
• Flexible working hours and fully remote work options.
• Career development opportunities.