GMP Engineer

E-Solutions Inc.; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading engineering solutions provider is seeking a GMP Engineer in Indianapolis, IN. You will plan and execute commissioning and qualification activities for new equipment, ensuring compliance with regulatory standards like GMP and FDA. The ideal candidate has a Bachelor’s degree and at least five years of experience. Responsibilities include maintaining documentation, supporting audits, and collaborating with diverse teams. This role offers opportunities for growth and involvement in innovative engineering projects.

Qualifications

• Minimum of five years of experience in commissioning, validation, or qualification.
• Strong understanding of GMP, GAMP, and FDA regulatory standards.
• Experience executing IQ, OQ, and PQ protocols.

Responsibilities

• Plan and execute commissioning and qualification activities for new equipment.
• Maintain detailed documentation related to commissioning and qualification activities.
• Ensure compliance with industry regulations during audits.

Skills

GMP

GAMP

FDA regulatory standards

Technical writing

Problem-solving

Cross-functional teamwork

Education

Bachelor’s degree in Engineering, Science, Business, Management, or a related field

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Microsoft Visio

Job description

GMP Engineer page is loaded## GMP Engineerlocations: Indianapolis, IN (MEP-SOL)time type: Full timeposted on: Posted Yesterdayjob requisition id: JR105361## Key Responsibilities### Commissioning & Qualification* Plan and execute commissioning and qualification activities for new equipment and systems.* Develop and execute **IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)** protocols.* Ensure equipment and systems are installed correctly and operate according to design specifications.* Prepare and complete post-execution summary reports following qualification activities.### Documentation & Compliance* Maintain detailed documentation related to commissioning and qualification activities.* Generate comprehensive validation and qualification reports.* Ensure documentation meets regulatory and quality compliance standards.### Regulatory & Quality Assurance* Maintain knowledge of industry regulations including **FDA, GMP, and GAMP** guidelines.* Develop and maintain validation procedures aligned with regulatory requirements.* Support internal and external audits related to system validation and regulatory compliance.### Collaboration* Work closely with engineering teams, quality assurance, and regulatory personnel.* Collaborate with clients, vendors, and suppliers to ensure systems and equipment meet required specifications.* Provide training to team members on commissioning, validation, and qualification procedures.### Troubleshooting & Continuous Improvement* Identify and resolve deviations during commissioning or qualification activities.* Develop and implement corrective and preventive actions (CAPAs).* Perform risk assessments to identify potential system performance issues.* Participate in continuous improvement initiatives related to system validation and compliance.## Qualifications* Bachelor’s degree in **Engineering, Science, Business, Management, or a related field**.* **Minimum of five (5) years of experience** in commissioning, validation, or qualification within a regulated manufacturing or industrial environment.* Strong understanding of **GMP, GAMP, and FDA regulatory standards**.* Experience executing **IQ, OQ, and PQ protocols**.* Proficiency in Microsoft Office applications including **Excel, Word, Outlook, and Visio**.* Strong technical writing and documentation skills.* Excellent problem-solving and troubleshooting abilities.* Ability to work independently as well as collaboratively in cross-functional teams.## Travel Requirements* Ability to travel **approximately 20–30%** to customer locations or project sites as needed.## Physical Requirements* Prolonged periods of sitting while working at a desk or computer.* Ability to occasionally lift up to **15 pounds**.* Ability to travel and work at various project or client sites.## Work Environment* Office and engineering environment with occasional work at industrial or manufacturing facilities.* Collaboration with engineering, validation, and regulatory teams on complex project environments.E Solutions was built in response to customers seeking a smarter, more sustainable “green” approach to industrial systems. From day one, we’ve been committed not only to meeting those needs — but to exceeding them.Our team brings decades of experience in automation, HVAC, and contracting, with experts in mechanical, chemical, electrical, and environmental engineering. This diverse expertise allows us to design, install, and integrate a wide range of industrial systems, delivering solutions that are highly capable, cost-efficient, and user-friendly. Whether it’s aircraft de-icing, security systems, or specialized controls, we create the tools our customers need to operate seamlessly. To keep things running at peak performance, we also provide preventative maintenance and alert monitoring services. As a proud division of MEP Holdings — a company with more than 500 employees — E Solutions combines deep industry knowledge with the resources of a larger network to deliver reliable, innovative results.