Process Validation Specialist
1 month ago
At Lonza, we're committed to delivering high-quality products and services that make a meaningful difference in people's lives. As a Senior Process Validation Engineer, you'll play a critical role in ensuring the timely and successful validation of new technology transfers into our production facility.
Key Responsibilities:- Lead the execution of process validation activities and studies to support commercial customers.
- Author validation protocols and reports, and develop validation plans to meet scheduled timelines.
- Participate in review and approval of PV protocols and reports, and review minor/major deviations.
- Provide floor and on-call support for PV activities, and maintain oversight of ongoing PV activities.
- Lead investigations into discrepancies and deviations, and author discrepancy reports or minor/major deviations.
- Identify and drive implementation of process improvements as required.
- Support change implementation on site, and manage change control implementation for changes driven by PV studies/improvement.
- Participate in inspections and audits by internal QA, customer, and regulatory authorities as required.
- Degree or higher from a recognized institution in Engineering/Science.
- 5-7 years' experience in Validation or a related manufacturing environment in the Biopharmaceutical industry.
- Familiarity with regulatory requirements and local codes & standards (e.g., FDA, EMEA, GAMP, and ICHQ7).
- Good knowledge and experience of the practical and theoretical requirements of validation programs in GMP facilities.
- Excellent oral and written communication skills, action orientation, and ability to work well in a cross-functional technical environment.
At Lonza, we value our people and our environment. We're committed to delivering high-quality products and services that make a meaningful difference in people's lives. If you're passionate about process validation and want to join a team that shares your values, apply now
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