Highlights
Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world s leading organizations in a broad range of industries. Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution.
Numbers & Facts
| Location | Marietta, GA |
| Industry | Computer Software |
| Company Size | 20 to 49 employees |
| Year Founded | 2014 |
| Website | http://www.tekfortune.com/ |
Description
Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world s leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work. To support the active project demands and skills gaps, our staffing experts can help you find the best job for you.
Role: Manufacturing Engineer
Location: Marietta, Georgia
Duration: 6 months
Required Skills: Manufacturing Engineer
Job Description:
The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility. The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.
Key Responsibilities:
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes
Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards
Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution
Support equipment installation, commissioning, and troubleshooting activities
Ensure adherence to Good Manufacturing Practices (GMP) and quality systems
Perform risk assessments (FMEA) and contribute to process improvements
Maintain accurate documentation, traceability, and validation records
Participate in process optimization and continuous improvement initiatives
Support audits, inspections, and regulatory submissions as needed
Required Skills & Competencies:
Bachelor s degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience
Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
Knowledge of medical device regulations (FDA, ISO 13485)
Experience in manufacturing processes, equipment qualification, and process validation
Familiarity with GMP, CAPA, and change control processes
Ability to read and interpret engineering drawings, P&IDs, and technical specifications
Strong problem-solving and analytical skills
Excellent communication and documentation skills
Preferred Qualifications:
Experience in medical device or regulated manufacturing environment
Exposure to cleanroom manufacturing environments
Familiarity with statistical tools and validation software
Experience supporting automation systems or complex manufacturing equipment
Work Environment:
Full-time onsite role in a regulated medical manufacturing facility
Requires collaboration with cross-functional teams and shop-floor presence
Key Deliverables:
Approved IQ/OQ/PQ protocols and reports
Equipment qualification and validation documentation
Compliance with regulatory and quality standards
Timely execution of validation and production readiness activities
For more information and other jobs available please contact our recruitment team at
Role: Manufacturing Engineer
Location: Marietta, Georgia
Duration: 6 months
Required Skills: Manufacturing Engineer
Job Description:
The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility. The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.
Key Responsibilities:
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes
Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards
Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution
Support equipment installation, commissioning, and troubleshooting activities
Ensure adherence to Good Manufacturing Practices (GMP) and quality systems
Perform risk assessments (FMEA) and contribute to process improvements
Maintain accurate documentation, traceability, and validation records
Participate in process optimization and continuous improvement initiatives
Support audits, inspections, and regulatory submissions as needed
Required Skills & Competencies:
Bachelor s degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience
Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
Knowledge of medical device regulations (FDA, ISO 13485)
Experience in manufacturing processes, equipment qualification, and process validation
Familiarity with GMP, CAPA, and change control processes
Ability to read and interpret engineering drawings, P&IDs, and technical specifications
Strong problem-solving and analytical skills
Excellent communication and documentation skills
Preferred Qualifications:
Experience in medical device or regulated manufacturing environment
Exposure to cleanroom manufacturing environments
Familiarity with statistical tools and validation software
Experience supporting automation systems or complex manufacturing equipment
Work Environment:
Full-time onsite role in a regulated medical manufacturing facility
Requires collaboration with cross-functional teams and shop-floor presence
Key Deliverables:
Approved IQ/OQ/PQ protocols and reports
Equipment qualification and validation documentation
Compliance with regulatory and quality standards
Timely execution of validation and production readiness activities
For more information and other jobs available please contact our recruitment team at
careers@tekfortune.com
. To view all the jobs available in the USA and Asia please visit our website at https://www.tekfortune.com/careers/ .About Company
Tekfortune is a software solutions company providing project development and staff augmentation services to companies in various industries including Healthcare, Banking, Finance, Telecommunication and Aviation.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.