About Us
At cGMP Consulting, we specialize in providing expert validation, qualification, compliance, and project management 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 engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. A process engineer has general knowledge of other related disciplines beyond their own area of expertise.
Responsibilities
The essential functions include, but are not limited to the following:
- Responsible for compliance with applicable policies and procedures.
- Independently plan and conduct small to medium size projects within engineering specialty requiring conventional types of plans, investigations and or equipment.
- Managed multiple, concurrent, projects and meet deadlines.
- Leads the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches.
- Communicates tasks and issues amongst project teams and stakeholders.
- Actively participates in on the floor activities and execution of studies in support of new equipment and/or process development.
- Translates development findings into a manufacturing process that can be implemented within the plant.
- Generate and execute tech transfer protocols, risk assessments, and reports for new product introductions to the Pleasant Prairie manufacturing site.
- Identifies and implements best practices and procedures designed to provide robust manufacturing processes.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
- Provides technical support for Investigations, Action Plans, Gap Assessments and Material Change Requests, etc. as required.
- Creates Standard Operating Procedures based on experience and updates Standard Operating Procedures.
- Perform any other tasks/duties as assigned by management.
Requirements
- Bachelors’ degree in Engineering, Science, or a related field of study.
- 4+ years’ experience in a GMP manufacturing environment. Must be familiar with regulatory (FDA) requirements.
- Possess strong technical knowledge and application of concepts, practices and procedures.
- Strong stakeholder relationship management, especially with technical, data, and business teams.
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.
Top Skills
What We Do
Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.
