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 position is based in Rockville, Maryland.

Position Summary

cGMP Consulting is seeking a motivated and detail-oriented individual to lead and manage a variety of on-going projects in the pharmaceutical industry. This individual will support designating project resources, managing project schedules, monitoring progress, communicating status, and ensuring successful project completion. The ideal candidate has knowledge in DeltaV and a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Responsibilities

Develop and manage project deliverables and objectives to accomplish assigned projects
Manage and use a DeltaV Automation Program
Prepare and communicate project schedules and resource needs to internal and external teams
Manage issues and risks that arise throughout project
Ensure projects are progressing as planned and adjust or reallocate resources to accommodate any changes or risks
Work with client representatives to fully understand needs and solve problems
Provide quality and validation expertise to determine compliance needs
Communicate resource needs to the cGMP Consulting team to ensure continued project success and completion
Schedule, lead, and participate in meetings and discussions related to assigned client projects
Develop good relations with colleagues and clients
Assist in project forecasting and effectively plan requirements for upcoming tasks
Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols
Utilize Word, Excel, Document Management Systems, and other electronic tools to complete tasks efficiently
Perform additional tasks or duties as assigned by management

Requirements

Bachelor's degree in Engineering, Science, or a related field of study
5+ years’ experience in a GMP manufacturing environment; familiar with regulatory (FDA) requirements
2-5 years’ experience with DeltaV Automation Platform
Superior organizational, communication, and interpersonal skills
Project Management Professional (PMP) certification is a plus
Detail oriented and comfortable working in a fast-paced office environment

Compensation and Benefits

Expected pay range per year: $85,000-$100,000 USD
Benefits include medical, dental, vision, PTO, and 401(k)

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, a drug‑free workplace, and complies with ADA regulations as applicable.

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