PharmEng Technology
About the job Validation Engineer
Job Title: Validation Engineer Lyophilization Specialist
Location: Sanford, NC (Long-Term Contract)
About the Role: We are seeking an experienced Validation Engineer specializing in lyophilization processes and equipment. The ideal candidate will lead validation activities, ensuring compliance with regulatory standards while supporting manufacturing excellence in a pharmaceutical or biotech setting.
Key Responsibilities:
- Develop and execute validation protocols for lyophilization equipment and processes.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for lyophilizers.
- Create, review, and maintain validation documentation, including protocols, reports, and risk assessments.
- Conduct validation testing to meet regulatory and industry compliance standards.
- Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing.
- Address validation issues and implement corrective and preventive actions (CAPA).
- Stay updated on industry trends and regulatory changes related to lyophilization and validation.
- Participate in audits concerning validation processes.
- Provide training and guidance on validation protocols and best practices.
- Bachelors degree in Engineering, Life Sciences, or a related field.
- Extensive experience in lyophilization validation within the pharmaceutical or biotech industry.
- Strong understanding of GMP and regulatory requirements for equipment validation.
- Excellent analytical and problem-solving skills.
- Outstanding communication and team collaboration abilities.
- Experience with computerized system validation (CSV).
- Familiarity with validation software tools.
- Certification in validation engineering or related disciplines.
- Knowledge of Lean or Six Sigma methodologies.
Apply Now: If you are a detail-oriented Validation Engineer with expertise in lyophilization, we encourage you to apply and contribute to cutting-edge pharmaceutical advancements. This is a unique opportunity to work on impactful projects in a dynamic and innovative environment.