GMP Engineer
E-Solutions Inc.
Key Responsibilities
Commissioning & Qualification
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.
- Maintain detailed documentation related to commissioning and qualification activities.
- Generate comprehensive validation and qualification reports.
- Ensure documentation meets regulatory and quality compliance standards.
- 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.
- 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.
- 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.
- 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.
- Ability to travel approximately 20-30% to customer locations or project sites as needed.
- 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.
- Office and engineering environment with occasional work at industrial or manufacturing facilities.
- Collaboration with engineering, validation, and regulatory teams on complex project environments.
Vacancy posted 2 days ago
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