GMP Engineer

e Solutions•Indianapolis, IN

9d•Hybrid

About The Position

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.

Requirements

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.

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.