Product and Process Engineer - Maternity CoverRomaEUR 35.000 - 50.0002 giorni faProduct and Process Engineer - Maternity CoverApriliaEUR 35.000 - 50.000About the roleResponsible for development, validation and technology transfer of manufacturing and cleaning processes. Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and stability. Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.Key responsibilitiesCoordinates, plans and executes 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.Authors documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, control charts, master formulas, experimental production orders where needed).Authors Qualitative e Quantitative Composition (QQC) for Dietary Supplement products.Authors production documentation (working instructions, master formulas, cleaning instructions, SAP Data Collection Forms) for routine manufacturing.Liaises 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.Analyzes stability data to support product shelf‐life, site programs (e.G. PPRs) and external evaluations (e.G. regulatory notifications and commitments).Coordinates de‐risking and business continuity projects related to raw materials, working closely with suppliers, Quality Supplier, Purchasing, Regulatory Compliance. Implements and maintains continued process verification (CPV), as appropriate, for determined products and processes on site. Incorporates 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.Leads or contributes 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.Performs assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensures appropriate validation is implemented. This includes HBEL, MACO, residual solvent calculations, and other assessments to support cleaning validation needs.Develops and works with Operations to execute protocols for cleaning validation, and issues validation reports.Updates SOPs regulating the department activities in line with company guidelines and regulations.Collaborates and supports 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.Collects and evaluates process data (in process control) and QC analytical data for report preparation.Collaborates and supports Production for technology issues in commercial productions.Observes current regulations and company provisions on workplace safety and hygiene and the use of collective protective equipment and personal protective equipment.Qualifications and skillsBS degree in Chemistry, Engineering, 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) and packaging technologies (blisters, sachets, sticks, bottles, tubes). Familiarity with microbiological sampling and experience in validation of probiotics products would be a plus.Experience with cleaning validation of GMP production areas.Knowledge of statistical softwares (eg. Statistica, Minitab).Good knowledge of written and spoken English.Strong relationship management, including the ability to work with inter‐functional teams and in a matrix organization with multiple stake‐holders interface.LocationApriliaContractMaternity CoverDiversity, Equity and InclusionAt Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Job Posting End DateAdjustment or Accommodations RequestIf you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We'll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.Note to candidatesThe Haleon recruitment team will contact you using a Haleon email account (@haleon.Com). If you are not sure whether the email you received is from Haleon, please get in touch.#J-18808-Ljbffr