PSocial network you want to login/join with: /ph3Functieomschrijving /h3pRandstad InHouse Services, specialty Pharma, is looking for a bProduct and Process Engineer /b. /ppAs a Product and Process Engineer, you will coordinate, plan, and execute technical aspects of development, validation, transfer of manufacturing and packaging processes, and equipment cleaning procedures. You will also contribute to identifying process and productivity improvement solutions. /ph3Responsabilità /h3pThis role offers you the opportunity to lead key activities to advance your career. Responsibilities include: /pulliTechnical coordination, planning, and execution of development and validation activities for manufacturing and packaging processes related to new product transfer, process improvement, and qualification of raw materials and packaging components. /liliPreparation and review of documentation for development and validation trials, such as protocols, reports, operative instructions, sampling plans, control charts, Master Formulas, and production orders. /liliDevelopment and validation of equipment cleaning procedures. /liliUpdating SOPs in line with company guidelines and regulations. /liliSupporting other plant functions (QA, QC, Regulatory, Procurement, Engineering) in technical evaluations and document preparations, including Change Controls, Deviations, Investigations, Risk Assessments, and PPRs. /liliAnalyzing process and QC data for report generation. /liliProviding technical support to Production for technological issues. /liliSupporting Operations and Opex in continuous improvement initiatives to enhance performance, productivity, and reduce losses. /li /ulh3Functie-eisen /h3ulliScientific University Degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biology, or Biotechnology. /lili2-5 years of experience in a GxP pharmaceutical environment. /liliExperience with process validation of various pharmaceutical and dietary supplement forms and packaging technologies. Familiarity with microbiological sampling and probiotics validation is a plus. /liliExperience with cleaning validation of GMP production areas. /liliKnowledge of statistical software (e.g., Statistica, Minitab). /liliProficiency in written and spoken English. /liliStrong relationship management skills and ability to work with cross-functional teams in a matrix organization. /li /ulpbLocation: /b Aprilia (LT) /ppbContract: /b Initial fixed-term contract of 12 months. /ppLa ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad ( ) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR). /p #J-18808-Ljbffr