Senior Process Validation Manager
Confidential
- Dublin, Dublin, Ireland
- Dublin, Dublin, Ireland
Über
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This role ensures that all equipment, facilities, utilities, automation, and cleaning processes are qualified and validated in strict accordance with current GMP guidelines.
You will optimize resource allocation globally to enhance manufacturing processes and consistently meet both internal standards and customer expectations.
Key Responsibilities Define, plan, and execute the validation strategy across a globally dispersed network; establish long-term goals for technical operations.
Provide technical direction and allocate resources efficiently to support global manufacturing sites and transfer programs.
Harmonize validation procedures across the network based on evolving regulations, industry standards, and science- and risk-based approaches.
Partner with Quality teams to oversee third-party validation protocols/reports and maintain continuous validation status through periodic system reviews.
Drive cross-functional shared learning, champion technological best practices, and ensure seamless process transitions into live operations.
Manage the compliant archival, filing, and electronic tracking of all validation data in accordance with site policies.
Candidate Requirements Education: Minimum of a Bachelor's degree in Engineering, Computer Science, or a related technical field.
Experience:
* 10+ years of validation engineering experience within a cGMP regulated years of post-graduate experience in high-volume manufacturing, ideally within the Medical Device or Pharmaceutical sectors. xyswxtq
Travel: Up to 5% annually (approximately 13 business days).
Benefits: Work From Home
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Sprachkenntnisse
- English
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