Product And Process Engineer

Product and Process Engineer - Fix Term ContractRomaEUR ***************3 giorni faOverviewWelcome to Haleon.We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions.In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories.What sets us apart is our unique blend of deep human understanding and trusted science.Now it's time to fully realise the full potential of our business and our people.We do this through our Win as One strategy.It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do.It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.ResponsibilitiesCoordinate, plan and execute development and validation of manufacturing processes and equipment cleaning procedures, working across multiple functions to collect the appropriate inputs for validation protocols and authoring validation reports.Author documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, control charts, master formulas, experimental production orders where needed).Author Qualitative e Quantitative Composition (QQC) for Dietary Supplement products.Author production documentation (working instructions, master formulas, cleaning instructions, SAP Data Collection Forms) for routine manufacturing.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.Analyze stability data to support product shelf-life, site programs (e.g. PPRs) and external evaluations (e.g. regulatory notifications and commitments).Coordinate de-risking and business continuity projects related to raw materials, working closely with suppliers, Quality Supplier, Purchasing, Regulatory Compliance.Implement and maintain continued process verification (CPV), as appropriate, for determined products and processes on site.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.Maintain and periodically review product control strategies (PCS) and technical risk assessments (TRA), as required.Lead or contribute to, as required, change controls impacting products or manufacturing processes.Ensures alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations.Perform assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensuring appropriate validation is implemented.This includes HBEL, MACO, residual solvent calculations, and other assessments to support cleaning validation needs.Develop and work with Operations to execute protocols for cleaning validation, and issues validation reports.Update SOPs regulating the department activities in line with company guidelines and regulations.Collaborate and support for technical aspects the other site functions (QA, QC, Regulatory, Procurement, Engineering) for evaluation / preparation of documents such as Change Controls, Master Formulas, deviations, investigations, Risk Assessments, Technical Assessments, Periodic Product Reviews (PPRs), User Requirement Functional Specifications (URFS), HACCP manuals.Collect and evaluate process data (in process control) and QC analytical data for report preparation.Collaborate and support Production for technology issues in commercial productions.Basic QualificationsScientific University Degree in Chemistry, Pharmacy, Pharmaceutical Technology and Chemistry, Chemical Engineering, Biology, Biotechnology.2 - 5 years experience in a GxP pharmaceutical regulated environment.Experience with process validation of pharmaceutical and dietary supplement products of different forms (coated / uncoated tablets, capsules, granules, creams).Experience with cleaning validation of GMP production areas.Good knowledge of written and spoken English.Preferred QualificationsStrong relationship management, including the ability to work with inter-functional teams and in a matrix organization with multiple stake-holders interface.Knowledge of statistical software (eg. Statistica, Minitab).Job Posting End Date#J-*****-Ljbffr