What are the responsibilities and job description for the Validation Engineer position at Veranova L P?
Job Description
Job Description
Company Description
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Job Description
The Validation Engineer will lead the validation program at our site, ensuring that all equipment, processes, and systems meet regulatory and quality standards. This role involves maintaining the Site Validation Standard Operating Procedures (SOP), developing validation protocols for new and existing equipment, and executing these protocols to verify compliance and performance.
Key Responsibilities / Accountabilities
- Validation Program Management : Oversee the entire validation lifecycle from planning to execution, documentation, and review.
- SOP Maintenance : Regularly update and maintain the validation SOPs to reflect best practices, regulatory changes, and operational needs.
- Protocol Development : Design and write validation protocols for new equipment installations, ensuring they meet both internal standards and regulatory requirements.
- Protocol Execution : Perform or coordinate the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This includes coordination with 3rd parties and contactors for SATs.
- Documentation : Ensure all validation activities are thoroughly documented, with accurate, compliant, and auditable records.
- Compliance : Monitor and ensure adherence to all relevant regulations (e.g., FDA, GMP, ISO) and company quality standards.
- Training : Provide training to staff on validation processes and compliance.
- Customer Focus : Participate in customer audits to be the SME for equipment validation on site.
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and / or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
