Validation Engineer

Join to apply for the Validation Engineer role at Pharm Eng Technology

Join to apply for the Validation Engineer role at Pharm Eng Technology

About The Job Validation Engineer

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.

Qualifications

• 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.

Preferred Skills

• 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.

Seniority level

• Seniority level
  
  Mid-Senior level

Employment type

• Employment type
  
  Full-time

Job function

• Job function
  
  Quality Assurance
• Industries Pharmaceutical Manufacturing

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