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
Information
Locations Marietta, GAPosition Open to Anywhere in the US, but will work on-siteIndustry ManufacturingStatus OpenJob Age 19 Day'sCreated Date 05/29/2026No.of Positions 15Duration 12Zip Code
