product and process engineer

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.

• 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.

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