Product and Process Engineer
3 giorni fa
Roma, Lazio, Italia
Haleon
Tempo pieno
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Welcome 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.
We are looking for a Product and Process Engineer to support Haleon managing critical projects to introduce new products and deliver cost saving opportunities. The role sits in the Technical Team, located at the Aprilia (LT) manufacturing site’s offices, reporting to Product & Technology Lead. This is a high-impact role, responsible for development, validation and technology transfer of manufacturing and cleaning processes. For this reason, you would be recognized as the principal point of contact for all aspects of knowledge on the product(s), performance and end to end process, including Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and stability. Responsibilities
* We will trust you with coordination, planning and execution of 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. In case of New Product Introductions, you will be part of cross-functional teams and will interact closely with external functions as well (e.g., Global R&D).
* You will author documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, master formulas, experimental production orders where needed). You will also update SOPs regulating the department activities in line with company guidelines and regulations.
* You will analyze stability data analysis to support product shelf-life, site programs (e.g. PPRs) and external evaluations (e.g. regulatory notifications and commitments).
* You will coordinate de-risking and business continuity projects related to raw materials, working closely with suppliers, Quality, Purchasing, Regulatory Compliance.
* You will 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.ou will also develop and work with Operations to execute protocols for cleaning validation, and issues validation reports.
* You will perform continued process verification (CPV), as appropriate, for determined products and processes on site, including 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. You will maintain and periodically review product control strategies (PCS) and technical risk assessments (TRA), as required.
* You will collaborate and support for technical aspects the other site functions (QA, QC, Regulatory, Procurement, Engineering) for evaluation / preparation of documents such as Change Controls, deviations, investigations, Technical Assessments, Periodic Product Reviews (PPRs), User Requirement Functional Specifications (URFS), HACCP manuals, as well as Production for technology issues in commercial productions.
Your profile
* Scientific University degree in Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Biology, Biotechnology, or related area.
* 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, probiotics) and cleaning validation of GMP production areas.
* Strong relationship management, including the ability to work with inter-functional teams and in a matrix organization with multiple stake-holders interface.
* Good knowledge of written and spoken English. EUR 40.661,00
- EUR 55.908,60The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience, skills, qualifications, and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in lin
We are looking for a Product and Process Engineer to support Haleon managing critical projects to introduce new products and deliver cost saving opportunities. The role sits in the Technical Team, located at the Aprilia (LT) manufacturing site’s offices, reporting to Product & Technology Lead. This is a high-impact role, responsible for development, validation and technology transfer of manufacturing and cleaning processes. For this reason, you would be recognized as the principal point of contact for all aspects of knowledge on the product(s), performance and end to end process, including Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and stability. Responsibilities
* We will trust you with coordination, planning and execution of 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. In case of New Product Introductions, you will be part of cross-functional teams and will interact closely with external functions as well (e.g., Global R&D).
* You will author documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, master formulas, experimental production orders where needed). You will also update SOPs regulating the department activities in line with company guidelines and regulations.
* You will analyze stability data analysis to support product shelf-life, site programs (e.g. PPRs) and external evaluations (e.g. regulatory notifications and commitments).
* You will coordinate de-risking and business continuity projects related to raw materials, working closely with suppliers, Quality, Purchasing, Regulatory Compliance.
* You will 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.ou will also develop and work with Operations to execute protocols for cleaning validation, and issues validation reports.
* You will perform continued process verification (CPV), as appropriate, for determined products and processes on site, including 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. You will maintain and periodically review product control strategies (PCS) and technical risk assessments (TRA), as required.
* You will collaborate and support for technical aspects the other site functions (QA, QC, Regulatory, Procurement, Engineering) for evaluation / preparation of documents such as Change Controls, deviations, investigations, Technical Assessments, Periodic Product Reviews (PPRs), User Requirement Functional Specifications (URFS), HACCP manuals, as well as Production for technology issues in commercial productions.
Your profile
* Scientific University degree in Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Biology, Biotechnology, or related area.
* 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, probiotics) and cleaning validation of GMP production areas.
* Strong relationship management, including the ability to work with inter-functional teams and in a matrix organization with multiple stake-holders interface.
* Good knowledge of written and spoken English. EUR 40.661,00
- EUR 55.908,60The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience, skills, qualifications, and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in lin