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As a modern employer, we empower you to be yourself, share ideas and work collaboratively
The Process Engineer is responsible to design and implement highest standard solutions and promote continuous improvement of process equipment and systems within the assigned business segment, by pushing on boundaries of technology.
The successful candidate will work in strong collaboration with manufacturing and QA and full alignment with Manufacturing Units, Central and Site Engineering.
In this role you will have the following responsibilities:
- Design and execute process technology projects in the following business segments: Aseptic Operations for Rosia plant;
- Drive execution of process engineering capex, with focus on standardization, robustness, harmonization of ways of working, systematic approach. Ensure effective reporting to Process Engineering Manager;
- Ensure that all process engineering documents are maintained updated;
- Ensure the execution of projects within the approved scope, time schedule and budget. Ensure effective reporting to Process Engineering Manager;
- Provide smooth handover of projects for new installations by proper involvement of stakeholders in all critical projects steps.
- Ensure adherence to cGMP's, GES, standard operating procedures, safety practices;
- Monitor quality metrics of the assigned process engineering activities in close collaboration with QA. Ensure effective reporting to Process Engineering Manager;
- Responsible to support audits for topics related to his/her area of responsibility;
- Design solution to fix all process engineering gaps outcomed from Regulatory/Agency Inspection, Audit, Integration/remediation programs and all initiatives to improve compliance level (GMP and HSE).
- Budgeting, forecasting and cost control of minor capex;
- Health, Safety Environment;
- Ensure full compliance with all company policies, procedures, safety rules, and regulations;
- Ensure a cultural approach in terms of safety, behaviors and design.
- Propose to Lead/Manager personal development program to meet future objectives of the business;
- Is part of an organization updated to the latest state of art of engineering, values-based, with high-performance level and service culture.
- Management of external resources staffed in the Team.
- Could be “Preposto per la sicurezza” as per Italian law D.Lgs 81/2008.
- Degree in Chemical Engineering;
- At least 3 years of experience in Pharmaceutical/Biotech Company and in Engineering Department;
- Capability to manage multiple projects;
- Understanding of finance related to Capital Projects;
- Fluent English and knowledge of local language (Italian);
- Ability to read and understand engineering drawings (P&IDs, Electrical Schematics, Control Loop Diagrams, Architectural, and Process Flow Diagrams, etc.);
- Quantify and analyze system performance, identify performance gaps through continuous improvement tools and make recommendations for improvement to ensure reliability for operations;
- HVAC (design and troubleshooting on air handling units);
- Facility design (Material/People flow, clean rooms);
- Clean Utilities (Generation and distribution of Pure Fluids, principles, troubleshoting and design standards);
- Sterility (sterilization principles, Dry heat/depirogenation, eBeam, gamma radiation, isolators);
- Fill finish isolators;
- Decontamination (Autoclaves, EDS, Incinerators, batch decontamination);
- Cleaning (cleaning standards and principles, CIP/SIP, COP/SOP, washing machines);
- Upstream/Downstream Process Operation (cell harvest, centrifugation, purification, chromatography, filtration)
- Team Working capability;
- Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration;
- Demonstrates conceptual, analytical and strategic thinking;
- Effective at problem solving and conflict resolution;
- Ability to deal calmly with complex managerial and technical issues;
- Proven influencing skills with the demonstrated ability to act with confidence and credibility in- and outside the Company;
- Ability to operate cross-functionally and work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.