Computer System Validation Specialist for Pharma, Italy
We are looking to expand our Advisory and Consultancy division with several CSV (Computer System Validation) specialists with expertise in the Life Science industry.
We expect the candidate to have a demonstrable background in either CSV or Process Validation consultancy to large pharma or biotech enterprises. To be successful, you will have good technical and communication skills and a strong motivation.
- Support our Customers validation projects by:
- Defining and writing Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
- Writing and reviewing Standard Operating Procedures and Work Instructions.
- Drafting of Design and Functional Specification documents in cooperation with our System or Process Engineers and managing formal revision and approval processes.
- Writing and executing IQ/OQ/PQ test protocols for computer systems, processes, equipment and utilities.
- Performing Technical Impact Assessments.
- Writing and reviewing Calibration and Maintenance Plans.
- IT/OT Infrastructure Qualification plan, tests and procedures writing and review.
- Provide cross-functional cooperation with our Engineering Teams:
- Learn foundations of IT, OT and process engineering.
- Facilitate interdepartmental Quality, Engineering, IT communications .
- Support internal quality processes .
- Support documental standardisation.
- Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
- Minimum 2 years previous consulting experience in Computer Systems Validation and/or Product/Process Validation in the pharmaceutical sector.
- Language skills: Italian and English CEFR C1 level or higher (read, written and spoken – the interview will be held in both languages).
- Utmost professionalism and seriousness towards customers and colleagues.
- Care towards the relationship with and to the management of the Customer.
- European citizen or possession of a valid residence and work permit in the European Community commencing employment start date.
- Complete autonomy in the professional use of the following software / IT tools:
- Google Mail (email and company chat)
- Google Documents (drafting of documents and letters, minutes, formatting and organisation of text, etc.)
- Google Sheets (data entry, use of the basic formulas, data extraction and use of pivot tables)
- It is recommended to complete the free online courses offered by Google for the “workspace business user” learning path: https://cloud.google.com/training/workspace/#workspace-business-user-learning-path
- Scientific/tech high school diploma or university degree.
- Driving licence B or equivalent recognized in the EU and valid.
Nice to have
- Previous work experience in multinational companies, or on their behalf.
- Pevious experience in IT infrastructure qualification or validation of any pharma manufacturing equipment, QC and Lab applications, SAP, LIMS systems, etc.
- Candidates providing pertinent references, ISPE training records or certifications.
- Primary job locations: Bologna e Faenza, Italy (2 vacancies).
- Travel: n.a.
- Type: Full time
- Business unit: Advisoru and Consultancy
- Level and salary: employment contract of the Confcommercio Tertiary National Collective Labour Agreement with a classification between L3 and L1 depending on the actual experience achieved + bonus, training and welfare plan (backgrounds and expertise will be assessed).
What We Offer
Ample opportunity for career development.
Full-time employment contract of the Confcommercio Tertiary National Collective Labour Agreement with a classification between L3 and L1 depending on the actual experience achieved.
Objective plan and bonuses starting from the fourth month.
Standard MAASI personal treatment:
access to the corporate welfare plan,
meal vouchers (accrued for each day worked not in smart working, in a accordance with the current legislation),
reimbursement of travel and any expenses incurred,
overtime always paid according to legislation,
training and development plan, etc.
A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.
Internal and external trainings specifically selected on your aptitudes and talent.
A set of benefits, services and affiliations on top to the profession's health insurance.
We're a Company of human beings, before anything else. You'll never be "just a number" here.