Senior Process Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Sr. Process Engineer. You will leverage your expertise in quality systems, change management, and process improvements to drive compliance and innovation in packaging and labeling. This role requires a strong understanding of regulatory requirements and cross-functional collaboration. You will maintain and enhance quality systems, develop SOPs, lead change management strategies, and manage label change requests. The position offers a competitive salary, robust benefits, flexible work options, and career development opportunities. Syner-G BioPharma Group was recently recognized as a Best Place to Work, highlighting its commitment to employee well-being and growth.

Requirements

• Possess a Bachelor’s degree in Engineering, regulatory affairs, or a related field
• Have a minimum of 7-11 years of experience in pharmaceutical packaging and labeling, with specific expertise in sterile injectables and medical devices
• Demonstrate a deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes
• Show proficiency with quality systems including change control and quality events, proficiency in labeling equipment, label artwork review, and compliance
• Demonstrate demonstrated success in managing multiple projects in parallel
• Possess excellent communication skills with the ability to work effectively across departments and influence stakeholders

Responsibilities

• Maintain and enhance packaging and labeling quality systems to ensure compliance with FDA, EMA, and related regulations
• Develop/improve standard operating procedures (SOPs), work instructions, and quality documentation related to packaging and labeling processes with a focus on lifecycle management
• Lead and implement change management strategies for packaging and labeling, supporting product lifecycle changes and minimizing operational impact
• Manage and review label change requests (LCR) to ensure timely, accurate, and compliant label updates
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach
• Plan, execute, and oversee packaging and labeling projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams
• Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance
• Analyze existing packaging and labeling workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk
• Drive continuous improvement initiatives to streamline labeling and packaging processes, enhancing compliance, productivity, and cost-effectiveness
• Provide technical expertise and troubleshooting support for packaging and labeling issues, including root cause analysis and corrective action planning
• Support manufacturing labeling operations including support, issue trending, and improvement projects
• Ensure that all packaging and labeling specifications meet regulatory/process standards
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align labeling strategies with overall business objectives
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”