Job Overview:
Pay Range: $92.41hr - $97.41hr
Requirement/Must Have:
- 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.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
- Strong 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.
Responsibilities:
- Lead and manage Corrective and Preventive Action (CAPA) investigations and activities.
- Support validation activities, including equipment, process, facility, computerized systems, and documentation review.
- Collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
- Ensure regulatory compliance within the life sciences industry.
- Perform risk assessment and root cause analysis.
- Manage technical documentation and reporting.
- Drive continuous improvement and quality excellence.
Nice to Have:
- Experience in high-speed aseptic filling operations and sterile manufacturing environments.
Skills:
- 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.
Qualification And Education:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Master's degree preferred.
Benefits:
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.