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.
Responsibilities
- 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.
Must Have
- 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.
Position details
- 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.
Rewarding
A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.
Trainings
Internal and external trainings specifically selected on your aptitudes and talent.
Welfare plan
A set of benefits, services and affiliations on top to the profession's health insurance.
we're Humans
We're a Company of human beings, before anything else. You'll never be "just a number" here.