PharmEng Technology
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Validation Engineer
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PharmEng Technology Join to apply for the
Validation Engineer
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PharmEng 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 Referrals increase your chances of interviewing at PharmEng Technology by 2x Get notified about new Validation Engineer jobs in
Sanford, NC . Sanford, NC $87,480.00-$131,280.00 13 hours ago North Carolina, United States $45.00-$55.00 6 days ago North Carolina, United States 1 month ago North Carolina, United States $40.00-$45.00 6 days ago North Carolina, United States 18 hours ago Holly Springs, NC $50.00-$65.00 1 week ago Holly Springs, NC $70.00-$80.00 3 days ago North Carolina, United States 1 month ago Holly Springs, NC $120,000.00-$160,000.00 3 days ago Holly Springs, NC $55.00-$75.00 23 hours ago Holly Springs, NC $65,000.00-$104,439.00 1 week ago Quality Engineer, DSM Operations (Nights)
North Carolina, United States 7 months ago North Carolina, United States $50.00-$70.00 2 weeks ago Air Quality Engineer/Scientist with Expertise in Source Testing and Ambient Monitoring
North Carolina, United States 5 months ago Holly Springs, NC $80,465.00-$122,603.00 1 week ago Holly Springs, NC $40.00-$60.00 3 days ago Holly Springs, NC $70.00-$75.00 19 hours ago North Carolina, United States $60.00-$70.00 1 week ago Sanford, NC $106,300.00-$138,800.00 5 days ago Holly Springs, NC $60.00-$80.00 3 days ago Fuquay-Varina, NC $81,500.00-$95,000.00 4 days ago North Carolina, United States 3 weeks ago North Carolina, United States $119,800.00-$258,000.00 3 days ago Sr. Engineer, QA Operations (Tech Transfer)
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Validation Engineer
role at
PharmEng Technology Join to apply for the
Validation Engineer
role at
PharmEng 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 Referrals increase your chances of interviewing at PharmEng Technology by 2x Get notified about new Validation Engineer jobs in
Sanford, NC . Sanford, NC $87,480.00-$131,280.00 13 hours ago North Carolina, United States $45.00-$55.00 6 days ago North Carolina, United States 1 month ago North Carolina, United States $40.00-$45.00 6 days ago North Carolina, United States 18 hours ago Holly Springs, NC $50.00-$65.00 1 week ago Holly Springs, NC $70.00-$80.00 3 days ago North Carolina, United States 1 month ago Holly Springs, NC $120,000.00-$160,000.00 3 days ago Holly Springs, NC $55.00-$75.00 23 hours ago Holly Springs, NC $65,000.00-$104,439.00 1 week ago Quality Engineer, DSM Operations (Nights)
North Carolina, United States 7 months ago North Carolina, United States $50.00-$70.00 2 weeks ago Air Quality Engineer/Scientist with Expertise in Source Testing and Ambient Monitoring
North Carolina, United States 5 months ago Holly Springs, NC $80,465.00-$122,603.00 1 week ago Holly Springs, NC $40.00-$60.00 3 days ago Holly Springs, NC $70.00-$75.00 19 hours ago North Carolina, United States $60.00-$70.00 1 week ago Sanford, NC $106,300.00-$138,800.00 5 days ago Holly Springs, NC $60.00-$80.00 3 days ago Fuquay-Varina, NC $81,500.00-$95,000.00 4 days ago North Carolina, United States 3 weeks ago North Carolina, United States $119,800.00-$258,000.00 3 days ago Sr. Engineer, QA Operations (Tech Transfer)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr