PharmEng Technology ยท 15 hours ago
Validation Engineer
Sanford, NC
Full-time
Onsite
Senior LevelPharmEng Technology is 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.
ConsultingInformation TechnologyPharmaceutical
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
Qualification
Required
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
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
Company
PharmEng Technology
PharmEng Technology is a pharmaceutical company that provides consultancy services.
Founded in 1997
201-500 employees
H1B Sponsorship
PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Alan Kwong
Managing Director & CEO
Company data provided by crunchbase