IT Project Manager

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. This project is located in Petersburg, VA.

Position Summary
cGMP Consulting is seeking an experienced IT Project Manager with a strong background in pharmaceutical manufacturing to lead technology initiatives that support compliant, efficient, and digitized production operations. This role is responsible for planning, implementing, and governing IT projects that impact GMP environments, manufacturing systems, and enterprise technology platforms.

The ideal candidate has a proven track record managing cross-functional projects in regulated industries and understands the unique intersection of IT, automation, quality, and manufacturing operations.

Responsibilities

The essential functions include, but are not limited to the following:

• Lead end-to-end project lifecycle activities including scope definition, requirements gathering, scheduling, resourcing, budgeting, risk management, and execution.
• Manage multiple concurrent IT and manufacturing systems projects (e.g., MES, ERP, LIMS, automation integrations, data platforms).
• Develop clear project plans, charters, and communication strategies for stakeholders across IT, Quality, Manufacturing, Supply Chain, and Engineering.
• Partner with manufacturing, QA, validation, and engineering teams to align project delivery with GMP and operational needs.
• Facilitate workshops, requirements sessions, and steering committee updates.
• Coordinate with external vendors, software providers, and system integrators.
• Ensure all IT project deliverables meet GxP, 21 CFR Part 11, Annex 11, and internal quality system requirements.
• Work with QA and CSV/validation teams to develop validation plans, protocols, and documentation aligned with software development life cycle and industry best practices.
• Maintain project documentation consistent with audit and regulatory expectations.
• Support implementation and enhancement of manufacturing technology such as, MES (e.g., Werum PAS-X, Rockwell PharmaSuite), ERP (e.g., SAP S/4HANA), LIMS / ELN, SCADA, equipment integration, data historians (e.g., PI), Serialization, traceability, and digital quality systems.
• Translate business and manufacturing requirements into system specifications and functional designs.
• Troubleshoot and escalate complex technical issues with appropriate teams.
• Drive process standardization, integration, and digital transformation initiatives within manufacturing IT.
• Identify opportunities to optimize system performance, data flows, and compliance posture.
• Contribute to long-term technology roadmaps and system upgrades.

Requirements

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field.
• 5+ years of IT project management experience, with at least 3 years in pharmaceutical, biotech, or regulated manufacturing.
• Strong understanding of GMP, CSV, GxP regulations, and computerized system validation.
• Demonstrated success leading cross-functional IT/mfg system projects.
• Excellent communication, organizational, and stakeholder management skills.
• Experience with common project methodologies (Waterfall, Agile, or hybrid).

Compensation and Benefits

• Expected pay range per year: $90,000-$100,000 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.