Functieomschrijving
Randstad InHouse Services, specialty Pharma, is looking for a Product and Process Engineer.
As 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 and ensure knowledge transfer to production departments. You will also contribute to the identification of process and productivity improvement solutions.
Responsabilità
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
* Technical coordination, plan and execution of development / validation activities of manufacturing / packaging processes relevant to the transfer of new products, improvement / maintenance of current processes and qualification of new raw materials (active ingredients / excipients) and packaging components.
* Coordination, preparation and review of documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, control charts, Master Formula, production orders).
* Coordination, plan and execution of development / validation activities for equipment cleaning procedures.
* Update of SOP regulating the department activities in line with company guidelines and regulations.
* Collaboration and support for technical aspects to other plant 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.
* Collection and evaluation of process data (in process control) and QC analytical data for report preparation.
* Collaboration and support to Production for technological issues in commercial productions.
* Technical support to Operations and Opex for continuous improvements/simplification initiatives impacting performance, productivity and loss reduction.
Functie-eisen
* Scientific 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) 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.
Location: Aprilia (LT)
Is offered: inixial fixed-term contract of 12 months.
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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