Senior Process Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Project Engineer. This role focuses on leveraging expertise in project management and process improvements within pharmaceutical manufacturing and packaging. You will maintain and enhance quality systems, lead change management strategies, and manage projects from concept to implementation. The ideal candidate possesses extensive experience in pharmaceutical manufacturing and packaging, a deep understanding of relevant regulations, and strong project management and communication skills. Syner-G offers a competitive salary, robust benefits, flexible work options, and career development opportunities.

Requirements

• Bachelor’s degree in Engineering, regulatory affairs, or a related field
• Minimum of 7-11 years of experience in pharmaceutical manufacturing and packaging, with specific expertise in equipment management
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to manufacturing and packaging
• Proficiency with quality systems including change control and quality events, proficiency in manufacturing and packaging equipment, and compliance
• Demonstrated success in managing multiple projects in parallel
• Excellent communication skills with the ability to work effectively across departments and influence stakeholders
• Strong project management skills, with the ability to manage multiple projects simultaneously
• Strong leadership and team management abilities
• Detail-oriented with strong analytical and problem-solving capabilities
• Ability to work in a fast-paced, dynamic environment

Responsibilities

• 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 related to manufacturing and packaging processes with a focus on lifecycle management
• Lead and implement change management strategies for manufacturing and packaging, supporting product lifecycle changes and minimizing operational impact
• Manage and review equipment change requests to ensure timely, accurate, and compliant updates
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach
• Plan, execute, and oversee manufacturing and packaging 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 manufacturing and packaging workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk
• Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance, productivity, and cost-effectiveness
• Provide technical expertise and troubleshooting support for manufacturing and packaging issues, including root cause analysis and corrective action planning
• Support manufacturing operations including support, issue trending, and improvement projects
• Ensure that all manufacturing and packaging specifications meet regulatory/process standards
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align manufacturing 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
• Act as a product manager for manufacturing and packaging equipment, ensuring that product development aligns with market needs and regulatory standards
• Monitor market trends and competitor products to identify opportunities for innovation and improvement in manufacturing and packaging equipment
• Develop and maintain product roadmaps, ensuring alignment with business goals and customer needs
• Collaborate with marketing and sales teams to develop product positioning and messaging that differentiates our products in the market

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”