GMP Engineer III

Description

Seeking a GMP Engineer to ensure systems, equipment, and processes meet regulatory and quality standards. Join our team to plan and execute commissioning activities, develop qualification protocols, and maintain compliance with industry regulations.

• Develop protocols and test plans for IQ, OQ, and PQ.
• Generate comprehensive qualification reports in compliance with regulatory requirements.
• Suggest and implement process improvements for efficiency and compliance.
• Participate in continuous improvement initiatives related to commissioning and qualification processes.
• Plan and execute commissioning activities for new equipment or systems.
• Develop and implement corrective and preventive actions (CAPAs).
• Perform risk assessments to identify potential issues affecting equipment/system performance.
• Work closely with cross-functional teams, engineers, and regulatory affairs personnel.
• Provide training on commissioning and qualification procedures.
• Stay updated on industry regulations (FDA, GMP, GAMP) and ensure compliance.
• Ensure staff follows best practices.
• Collaborate with vendors to ensure equipment meets specifications.
• Maintain detailed records of commissioning and qualification activities.
• Implement and maintain validation procedures per regulatory guidelines.
• Identify and address issues during the commissioning and qualification process.
• Ensure correct installation and performance of equipment/systems.

Requirements

• Proficiency in generating and maintaining documentation.
• Proficiency in Microsoft Office (Excel, Visio, Outlook, Word, etc.).
• Strong understanding of industry regulatory requirements (FDA, GMP, GAMP).
• Effective communication and interpersonal skills.
• Attention to detail and commitment to quality.
• At least five years of related experience (preferred).
• Ability to work in a team and independently.
• Bachelor's Degree in Engineering, Science, Business, Management, or related field.
• Minimum five (5) years of experience in a commercial/industrial construction environment.
• Experience with commissioning and qualification processes.
• Strong problem-solving and troubleshooting skills.
• Excellent verbal and written communication skills.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance