• Bachelors in Engineering
• 3 years of experience in GMP packaging facility with process equipment.
• 2 year's industry experience in validation - writing and executing validation protocols.
• 3 years of industry experience in validation
Why GSK? Because GSK's vaccines business puts the customer at the heart of everything we do. That's why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers' needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.
Technical support of Secondary Packaging Manufacturing focusing on component and equipment troubleshooting, OEE, process improvement, reliability and troubleshooting process problems while meeting required quality, compliance and delivery targets.
• Ongoing support of Secondary Packaging Manufacturing including:
o Support EMT's in troubleshooting and problem resolution for equipment or component issues.
o Collect and analyze data to determine and drive process improvement projects to increase OEE.
• Support of new or modified components and equipment including:
o Creation of Change Controls
o Develop User Requirement Specifications and Briefs for the purchase or modification of packaging equipment and packaging components.
o Develop components in Agile
o Support the design, installation and qualification of packaging equipment and components ensuring harmonization with GSK standards.
o Author protocols and reports for packaging line trials and FAT, SAT, IQ/OQ, and PQ activities.
• Interface with Global Technical Services to support global packaging initiatives.
• Build network and collaborate with vendors and Local Technical Services to ensure effective and consistent transfer of technical knowledge and derive strategy and resolution to technical challenges.
• Participate in audits and investigations and recommend solutions to resolve problems. Assist in the writing and review of SOP's and batch records specific to technical details.
• Stay current on developments in the field of packaging equipment and process control technology and GSK- Vaccine Standards.
• Packaging Process expertise for secondary and tertiary packaging
• Experience with vision systems and serialization
• Validation experience for component and equipment changes
• Sufficient technical experience to:
o Influence and communicate effectively, both verbally and in writing, to all levels within the organization as well as to outside agencies.
o Analyze data and implement changes.
o Work with a sense of urgency, flexibility, accountability and integrity while balancing multiple priorities and responsibilities.
o Function in an atmosphere of constant change with detailed accuracy and quality while meeting goals or deadlines.
• Ability to establish and maintain effective working relationships cross functionally particularly with procurement, QA, QC, and production.
• Excellent organizational skills and attention to detail.
• Capable of working with minimal direct supervision.
• Must be a committed team player prepared to work in and embrace a team based culture.
• Stay current on developments in the field and GSK-Bio Standards.
• Up to 10% travel may be required to participate in vendor Factory Acceptance Tests and/or site visits to other GSK facilities
You may apply for this position online by selecting the Apply now button.
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