KODIAK Construction Recruiting & Staffing · 1 week ago
GMP Engineer
Indianapolis, IN
Full-time
Onsite
Senior Level
$95K/yr - $105K/yr
5+ years expKODIAK Construction Recruiting & Staffing is seeking a GMP Engineer to ensure systems, equipment, and processes meet regulatory and quality standards. The role involves planning and executing commissioning activities, developing qualification protocols, and maintaining compliance with industry regulations.
Staffing & Recruiting
Responsibilities
Plan and execute commissioning activities for new equipment or systems
Develop protocols and test plans for IQ, OQ, and PQ
Ensure correct installation and performance of equipment/systems
Maintain detailed records of commissioning and qualification activities
Generate comprehensive qualification reports in compliance with regulatory requirements
Stay updated on industry regulations (FDA, GMP, GAMP) and ensure compliance
Implement and maintain validation procedures per regulatory guidelines
Work closely with cross-functional teams, engineers, and regulatory affairs personnel
Collaborate with vendors to ensure equipment meets specifications
Identify and address issues during the commissioning and qualification process
Develop and implement corrective and preventive actions (CAPAs)
Perform risk assessments to identify potential issues affecting equipment/system performance
Mitigate risks through appropriate actions and documentation
Provide training on commissioning and qualification procedures
Ensure staff follows best practices
Participate in continuous improvement initiatives related to commissioning and qualification processes
Suggest and implement process improvements for efficiency and compliance
Qualification
Required
Excellent verbal and written communication skills
Proficiency in Microsoft Office (Excel, Visio, Outlook, Word, etc.)
Strong understanding of industry regulatory requirements (FDA, GMP, GAMP)
Experience with commissioning and qualification processes
Proficiency in generating and maintaining documentation
Strong problem-solving and troubleshooting skills
Effective communication and interpersonal skills
Attention to detail and commitment to quality
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
Preferred
At least five years of related experience
Company
KODIAK Construction Recruiting & Staffing
Pivot Workforce and Kodiak Labor Solutions recently merged and operate under the KODIAK brand.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase