Bachelor's degree in Engineering or Life Sciences; Master's preferred.
6-9 years in pharmaceutical or regulated manufacturing environments.
Strong quality validation, quality systems, and regulatory compliance background.
Experience leading CAPA investigations and management.
In-depth knowledge of Quality System Regulations (QSR) and GxP requirements.
Experience in validation activities like equipment, process, and system review.
Preferred experience in aseptic filling and sterile manufacturing.
Responsibilities
Lead quality validation and compliance activities.
Manage CAPA investigations and ensure timely resolution.
Support validation activities across various systems and processes.
Collaborate with cross-functional teams to enhance quality initiatives.
Conduct root cause analysis and risk assessments.
Review technical documentation for compliance and accuracy.
Drive continuous improvement efforts in quality and operational excellence.
Benefits
Health, dental, and vision insurance.
Retirement savings plan.
Paid time off and holidays.
Professional development opportunities.
Flexible work arrangements.
Full Job Description
Qualifications & Experience:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
Strong analytical and problem-solving skills with exceptional attention to detail.
bility to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
Key Competencies:
Quality Validation & Compliance.
CAPA Management.
Regulatory Knowledge (FDA, GMP, GxP, QSR).
Risk Assessment & Root Cause Analysis.
Cross-Functional Collaboration.
Project Management.
Technical Documentation & Reporting.
Continuous Improvement & Quality Excellence.
Skills need:
10+ years of experience in a Quality/Validation role.
Strong background in quality validation, quality systems, and regulatory. compliance within the life sciences industry.
Extensive CAPA experience.
Extensive Quality Systems Experience.
Extensive experience in high-speed aseptic filling operations and sterile manufacturing environments.
