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 multipleareas: cleaning validation qualification of aseptic filling or formulation equipment/processes qualification of component preparation equipment/processes and packaging.
• Hands-on experience with temperature validation equipment (e.g. Temptales Kaye etc.).
• Advanced critical thinking and technical writing skills.
• Strong organizational communication and interpersonal skills.

Compensation and Benefits

• Expected pay range per year: $85000-$100000 USD
• Expected benefits include: Medical Dental Vision PTO 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge skills or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer drug-free workplace and complies with ADA regulations as applicable.