GMP Engineer

E Solutions, LLC; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

E Solutions, LLC seeks a Validation Engineer in Indianapolis, IN to manage commissioning and qualification activities for new equipment. Candidates require a Bachelor's degree in a relevant field and at least five years of experience in a regulated environment.

The role involves ensuring compliance with FDA standards, maintaining documentation, and collaborating with engineering and regulatory teams. Occasional travel to client sites is required.

Qualifications

• Minimum of five years of experience in commissioning, validation, or qualification within a regulated environment.
• Experience executing IQ, OQ, and PQ protocols.
• Ability to work independently and collaboratively in teams.

Responsibilities

• Plan and execute commissioning and qualification activities.
• Maintain documentation related to commissioning and qualification.
• Develop and maintain validation procedures aligned with regulatory requirements.
• Identify and resolve deviations during commissioning or qualification activities.

Skills

Strong understanding of GMP, GAMP, and FDA regulatory standards

Technical writing and documentation skills

Problem-solving and troubleshooting abilities

Proficiency in Microsoft Office applications

Education

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

Tools

Microsoft Office

Job description

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.