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.