CSV Life Science Group, an international engineering company, market leader in the pharmaceutical sector, is looking for a Validation Specialist to join its CQV team in Milan and Latina offices.
The resource will be placed on a permanent contract. Grade level and salary will be commensurate with experience.
REQUIRED ACTIVITY
We are looking for a Validation Specialist for our Milan and Latina offices. The resource will join the CQV team and will be involved in structured projects for major players in the pharmaceutical industry. The resource will be responsible for drafting and executing qualification protocols in the field in accordance with predefined standards and ensuring compliance with relevant regulations. Specifically, she/he will perform the following activities:
- Drafting, verification and execution of qualification protocols (DQ, IQ, OQ, PQ) for equipment, for equipment, facilities, and controlled contamination environments.
- Performing thermal mapping studies for temperature/humidity-controlled environments and equipment.
Instrument calibration and verification activities.- Drafting and review of technical documentation: URS, VMP, Risk Assessment, GAP Analysis, P&ID.
- Qualification of HVAC systems, utilities (PW, WFI, Clean Steam), and process systems (RABS, isolators, autoclaves, freeze dryers).
Activities will include interfacing with customers and suppliers, meeting and coordinating with multi-disciplinary project teams.
REQUIRED CHARACTERISTICS:
The ideal candidate:
- Has a Bachelor’s or Master’s degree in a scientific discipline (engineering, chemistry, CTF or related).
- Is familiar with the relevant regulations (EU GMP, FDA, Annex 11, GAMP5).
- Has at least 3 years‘ experience in a similar role within the chemical-pharmaceutical sector.
- Has a good knowledge of English (both written and spoken).
- Has expertise in the validation of plants, equipment and processes in the chemical-pharmaceutical sector.
- He is familiar with the use of the main measuring instruments (multi-channel recorders, particle counters, anemometers, etc.).
- He is competent in CSV/Data Integrity.
- Has excellent organisational, interpersonal and deadline management skills.
This vacancy is open to candidates of all genders, in accordance with current legislation on equal treatment and non-discrimination (Legislative Decree 198/2006 and subsequent amendments).
All applications will be assessed on the basis of skills, experience and potential, without discrimination on grounds of gender, gender identity or expression, sexual orientation, age, ethnic or national origin, religion or personal beliefs, marital status or disability.
SEDE DI LAVORO
Milan and Latina.
WHAT WE OFFER
In CSV Life Science Group, you will find:
- Full-time permanent contract and salary commensurate with experience.
- Technical and soft skills training (in the classroom and on the job).
- Opportunities for professional development and growth within the Group.
- Integration into a dynamic, innovative, and rapidly growing environment.
- Employee welfare benefits and company benefits .
- Smart working and flexible hours compatible with field activities.
OUR CULTURE
In CSV Life Science Group, you will have the opportunity to work on unique and challenging projects, collaborate with the best experts in the field and build a growing career. You will develop your skills and reach new professional milestones within an ever-expanding group of a thriving international organization that values your growth and success.
We promote equal opportunity and are committed to a diverse and fair work environment. We believe that valuing diversity is the key to achieving great results and enriching our corporate culture.
