Senior Engineer

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry.

Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL.

Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.  Position Summary cGMP Consulting is seeking an experienced and driven individual to lead and manage multiple high-impact projects, including validation and qualification activities for equipment, utilities, facilities, systems and processes.

This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment.  The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols.

This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards.  Responsibilities  The essential functions include, but are not limited to the following :

• Lead the development and authorship of detailed specifications and supporting documentation (URS, RA, FS) for new processes, equipment and systems, ensuring alignment with regulatory expectations and project goals.
• Oversee and drive engineering projects involving facility modifications, equipment upgrades, or process improvements from concept through execution, providing technical direction and project leadership.
• Direct and coordinate equipment commissioning activities, working closely with cross-functional Engineering and Operations teams to ensure readiness for validation and production.
• Design, execute, and review complex validation / qualification studies for utility systems, equipment, cleaning, manufacturing processes, computerized systems, and new product introductions.
• Ensure compliance through robust protocol development, execution oversight, and authorship of final reports.
• Manage multiple concurrent qualification initiatives, proactively adjusting timelines and deliverables while communicating with stakeholders to ensure project alignment and successful execution.  Facilitate and lead cross-functional team meetings, providing strategic input, developing meeting agendas, documenting critical decisions, and ensuring timely follow-up on action items.  Contribute to capital project forecasting and long-term resource planning, ensuring engineering activities are adequately staffed and supported.  Provide technical oversight for analytical instrumentation, including programming, operating, and troubleshooting of temperature / humidity dataloggers and other tools used in environmental qualifications (e.g., lyophilizers, sterilizers, warehouses, incubators).  Collaborate with subject matter experts and manufacturing personnel to troubleshoot complex technical issues and implement effective, compliant solutions.  Act as a technical authority by identifying and recommending process and equipment optimizations based on performance data and industry best practices.  Lead the investigation and resolution of deviations, author change controls and implement CAPA strategies resulting from qualification or validation discrepancies.  Oversee the revision and implementation of SOPs, ensuring alignment with CAPA commitments, operational updates, and regulatory compliance.  Ensure adherence to all applicable company policies, training requirements, cGMP regulations, and safety standards, while serving as a mentor for junior team members on compliance best practices.  Leverage advanced proficiency with digital tools, including Microsoft Office, electronic Document Management Systems (eDMS), and Quality Management Systems (QMS), to streamline documentation and reporting.  Support broader site and departmental initiatives through the performance of additional leadership tasks or assignments as designated by management.  Requirements  Minimum Bachelors’ degree in Engineering, Science, or a related field of study.  5+ years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and / or reports.

Must be familiar with regulatory (FDA) requirements.  Expertise in multiple areas :