Product and Process Engineer, Randstad

Product and Process Engineer

Randstad

Location:

Italy, Aprilia

Category:

-

Contract Type:

Employment contract

Salary:

34000.00 - 40000.00 EUR / Year

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Job Description:

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. You will ensure knowledge transfer to production departments and contribute to the identification of process and productivity improvement solutions.

Job Responsibility:

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.

Requirements:

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.

Nice to have:

Familiarity with microbiological sampling
Experience in validation of probiotics products

What we offer:

Retribuzione annua: 34000€ - 40000€
Initial fixed-term contract of 12 months

Additional Information:

Job Posted:

April 06, 2025

Expiration:

May 18, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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