Engineer I

Job Title

cGMP Consulting is seeking a motivated and detail-oriented individual to support the execution of engineering activities for equipment, utilities, facilities, systems, and processes.

Job Description

This entry-level role offers the opportunity to gain hands-on experience in a dynamic, GMP-compliant manufacturing environment. The ideal candidate will excel in critical thinking, technical writing, and protocol execution while demonstrating the ability to work with limited supervision. This candidate should have a basic understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines. This position is open year round.

Responsibilities

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

• Assist in the setup, testing, and daily operation of new processes, equipment and systems in collaboration with Engineering teams.
• Perform validation and qualification tasks for equipment, utilities, cleaning procedures, computer systems, and/or new products.
• Execute validation/qualification studies for utilities, equipment, cleaning processes, computer systems, and new products, including protocol preparation and final report documentation.
• Support deviation investigations by collecting data, writing reports, and performing supplemental qualification activities.
• Author SOP updates and revisions related to processes, equipment and system modifications.
• Operate and program instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators).
• Collaborate with SMEs to identify and resolve technical challenges effectively.
• Maintain compliance with company policies, cGMPs, regulatory requirements, and safety protocols.
• Utilize tools such as Word, Excel, and electronic document management systems to complete tasks efficiently.
• Perform additional tasks as assigned by management.

Requirements

• Bachelors' degree in Engineering, Science, or a related field of study.
• 0-2 years' experience in a GMP manufacturing environment.
• Experience in technical writing including drafting standard operating procedures, protocols, and/or reports is preferred.
• Familiar with regulatory (FDA) requirements.
• Business minor or coursework is strongly encouraged.
• Advanced critical thinking and technical writing skills.
• Strong organizational, communication, and interpersonal skills.

Compensation and Benefits

• Expected pay range per year: $70,000-$85,000 USD
• Expected benefits include: Medical, Dental, Vision, PTO, 401K

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.