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. 

The ideal candidate will excel in leading multiple projects and priorities, efficient and comfortable working independently, support deadlines, and address high priority requests. This candidate should have a strong understand of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines. 

Responsibilities 

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

• 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 

• Bachelors’ degree in Engineering, Science, or a related field of study. 
• 5+ years’ experience in a GMP manufacturing environment. Must be familiar with regulatory (FDA) requirements. 
• 2-5 years' experience with DeltaV Automation Platform.
• Superior organizational, communication, and interpersonal skills are necessary.
• 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 
• 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.