Packaging Process Engineer: Product Quality & Validation

Haleon; Guía de Isora; Presencial; EUR 51.000 - 71.000; Jornada completa

Descripción de la vacante

Haleon is seeking a site packaging technical lead responsible for knowledge management of products, performance and end-to-end processes, including CQAs and CPPs. You will act as the site technical lead for packaging technologies, supplier change assessments and implementation, coordinating with QA, QC, Engineering and Operations to ensure products are manufactured in a validated state of control.

Responsibilities include leading change controls, CPV implementation, data analysis, validation

Formación

• BS degree in Chemistry, Engineering, or related area.
• Minimum of 3 years in Manufacturing Science, Product Development, or Technical Operations role.
• Knowledge of manufacturing and packaging equipment technology.
• Use of problem solving and continuous improvement tools.
• Project management.
• Fluent in English and Spanish are required.
• Experience in field or plant operations.
• Experience implementing FDA and/or GMP regulations.
• Knowledge and understanding of regulatory requirements for products, including packaging.
• Ability to articulate business vision to staff, peers, and senior executives.
• In-depth understanding of production forecasts and SAP systems.
• Problem Solving skills SAP, eBR, Serialization, Workday, Veeva, MyLearning, Office Teamwork.
• Strong communication skills; ability to inspire others to improve.

Responsabilidades

• Leads or contributes to, as required, change controls impacting products or manufacturing processes.
• Liaise with Regional and Global Technical, as well as other site functions such as QA, QC, Engineering, and Operations to ensure that proper controls are established and maintained for products to be manufactured in a validated state of control.
• Implement and maintain continued process verification (CPV), as appropriate, for determined products and processes on site, including packaging.
• Incorporate data trending and statistical analysis to verify that processes remain in a validated state of control, and to proactively identify trends which may provide risk to the product.
• Maintains and periodically reviews product control strategies (PCS) and technical risk assessments (TRA) as required.
• Provide all necessary information to develop and execute process validation, working across multiple functions to collect the appropriate inputs for validation protocols and approval of validation reports.
• Participates actively on validation of manufacturing and packaging process parameters necessary to assure product quality and incorporates this into the PCS.
• Lead or contributes to, as required, change controls impacting products or processes.
• Ensure alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations.
• Actively participates and defines technical transfer activities for incoming products to the site for OSD formulations mainly tablets, capsules and powders (sachets).
• Technical investigation and resolution of product issues and product improvements.
• Lead the resolution of Packaging issues and risks that could result in negative business impact, drawing on best practice from the packaging community and Haleon network of suppliers and external experts.
• Conduct investigations of process/packaging deviations to determine root cause/corrective actions.
• Lead site input to package design.
• Act as the “voice of packaging” for the site.
• Promote packaging initiatives for improvement in terms of simplification and efficiency
• Actively collaborate with other site relevant areas such as Manufacturing, Quality and Engineering for projects: material simplification, productivity, CAPEX integration with processes and materials.
• Lead and support the improvement projects related to the manufacturing and packaging process of products.
• Participate in the PCT (Performance Centric Teams) and supports HAPS deployment mindset as required.
• Technical approval for validation activities.
• Own and manage compliance records, including deviations, CAPAs, change controls, and events.
• Support responsible person for complaints during investigations/Investigation of complaints.
• Risk identification related to Safety, Quality, Supply, etc.
• Proactively solving problems to eliminate recurring issues.
• Project management for project assigned.

Conocimientos

Problem solving

Continuous improvement

Project management

Bilingual English/Spanish

Educación

BS degree in Chemistry, Engineering, or related area

Herramientas

SAP

eBR

Serialization

Workday

Veeva

MyLearning

Office Teamwork

Descripción del empleo

Haleon is seeking a site packaging technical lead responsible for knowledge management of products, performance and end-to-end processes, including CQAs and CPPs. You will act as the site technical lead for packaging technologies, supplier change assessments and implementation, coordinating with QA, QC, Engineering and Operations to ensure products are manufactured in a validated state of control.

Responsibilities include leading change controls, CPV implementation, data analysis, validation