Process Engineer-REMOTE US BASED
Manage Technical activities across multiple dosage forms with contract manufacturing companies and internal manufacturing sites to support product transfers, and new product introductions (NPIs) while partnering with QA, Commercial, R&D, and central Technical teams and internal sites to meet business needs.
• Lead complex technical troubleshooting and continuous improvement on CAPA effectiveness
• Ensure effective and efficient fit for purpose technical processes are in place to support Product Transfer, NPI, registration and launch.
• Work as GSK single point of accountability for all Technical activities across multiple CMOs producing GSK products.
• This is a key leadership role assuming full accountability for all Technical activities for CMOs within scope of Supplier Relationship Team (SRT) including:
o Product / Process assessments and continuous improvement at CMOs
o Oversight and implementation of validation activities impacting GSK products
o Troubleshooting and CAPA implementation / effectiveness for technical related issues
o Product transfer and NPI technical oversight and accountability
• Support the Americas Technical Support Lead in development and application of standard work across the CMO network, including implementation of Product Lifecycle Management (PLM) and Performance Management activities
• Work effectively within the matrix management structure to properly engage and drive performance from CMO Technical teams and pull in proper support from wider GSK network Technical resources when needed
• Support regional governance routines to track site performance vs plan and facilitate complex issue resolution.
• Develop and maintain the knowledge system to leverage troubleshooting experience and improve CAPA effectiveness
• Coach, mentor and develop technical talent within CMOs and internal sites.
• Represent the technical function and actively participate in regular SRT leadership meetings to drive business and Quality performance goals in the CMO network
• Colleague will work independently on most assignments and will be primarily accountable for identifying and prioritizing the projects / activities he / she is assigned to.
BS in Science or Engineering
Pharmaceutical, Chemical, Biochemical, Food science
Job requires sound decision making involving advanced understanding of various manufacturing technologies
Masters or other advanced degree, including technical certifications
Science or Engineering and/or Business
To demonstrate capability to develop deep technical knowledge and business understanding
Minimum 10- 15 years pharmaceutical/food manufacturing / technical environment
• Experience in CMO (Contract Manufacturing Operations) environment and knowledge of internal site capabilities.
• Experience in complex technical troubleshooting, RCA and CAPA effectiveness
• Leadership and execution of scale-up, tech transfers, process validation projects
• Strong project management, communication, negotiation, and problem-solving skills
• Excellent relationship Management and presentation skills.
Accountable for Technical operations at multiple CMOs, with significant product
complexity and spend
Executes Technical Transfer activities for products and processes into CMO organizations, including validation and
risk assessment activities
• Coach CMO and internal site Technical teams in developing technical capability and adopting standard work practices (i.e.Product Lifecycle Management)
• Lead resolution of complex technical problems through direct involvement or engaging matrixed global Technical
• Lead implementation of major Technical initiatives and foster exchange of best practices across sites in region
• Lead major manufacturing problem resolutions typically associated with supply interruptions and/or marketed
product action applying root cause analysis, design of experiments, and CAPA effectiveness trending
• Facilitate implementation and sustainability of major global initiatives within the CMO and internal network at a regional level
• Drive process improvements in CMO organizations that typically receive minimal capital investment due to tight
profit margins – role requires high degree of flexible thinking to merge business needs with limitations of investment, capability and resources at CMOs.
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