PPLM Technician (Product & Process Lifecycle)

About the role

Haleon is looking for a PPLM Technician in Alcalá de Henares to lead the Product & Process Lifecycle Management of products manufactured on site. The role acts as the site Product & Process Lifecycle subject matter expert, keeping the site product, process and cleaning state validated and controlled.

Key responsibilities

• Maintain the site product, process and cleaning state by assessing the impact of new products, processes or changes against the existing site cleaning matrix and process.
• Coach and develop the Technical team so that cleaning and manufacturing validation shows reproducible results and proper monitoring keeps processes in a validated state of control.
• Prepare and maintain the site validation master plan (SVMP) with Engineering, Quality and Technical departments, ensuring validation activities are on time and compliant with Haleon and Health Authority standards (e.g. MHRA).
• Ensure compliance with equipment and facility C&Q, process/packaging validation, cleaning validation, continued process validation (CPV) and computer system validation.
• Prepare and review technical documentation such as trials, TRA, PCS, validation documentation and investigations, and support the I&T area.
• Collaborate with Manufacturing, Quality and Engineering on projects such as material simplification, productivity and CAPEX integration, and lead improvement projects for the manufacturing process.
• Evaluate the validation impact on change controls, own and manage compliance records (deviations, CAPAs, change controls, events), support complaint investigations and identify risks across Technical, Safety, Quality and Supply.
• Manage assigned projects and participate in Performance Centric Teams (PCT) and HAPS deployment.

Required profile

• Bachelor's degree in engineering, industrial pharmacy, chemistry or another scientific or pharmaceutical discipline.
• At least 2 years of experience in a GMP-regulated technical role, with strong experience in process and cleaning validation.
• Fluent English and Spanish.
• Preferred: field or plant operations experience, experience implementing FDA and/or GMP regulations, understanding of production forecasts and SAP systems, and experience with SAP, eBR, serialization, Workday, Veeva, MyLearning and Office 365.

Required skills

• Problem-solving and continuous improvement tools
• Project management
• Data analytics and statistics