| Location | Indianapolis, IN |
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
Bachelors 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
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.