Overview
Validation engineer – life science Jobs in Medolla, Emilia-Romagna, Italy at Master Compliance
Location: Medolla
Job Title:
Validation Analyst / Validation Engineer Experience Level: 1–5 Years
Location:
Medolla & Grosotto.
Employment Type:
Contract Industry: Life Sciences Industry
Job Summary:
The Validation Analyst/Engineer will be responsible for supporting validation activities to ensure that systems, processes, equipment, and software comply with regulatory standards (e.g., FDA 21 CFR Part 11, Gx P, EU Annex 11). This role involves preparing, executing, and documenting qualification and validation protocols, collaborating closely with
cross-functional teams
to ensure compliance and quality in the development and deployment of systems.
Key Responsibilities:
Assist in the development and execution of validation protocols (IQ/OQ/PQ) for Gx P-regulated systems, software applications, lab equipment, and manufacturing systems.
Author and review validation deliverables such as Validation Plans, Risk Assessments, User Requirements (URS), Traceability Matrices, and Summary Reports.
Perform system testing including UAT (User Acceptance Testing) and ensure test results meet acceptance criteria.
Ensure systems meet regulatory requirements including FDA 21 CFR Part 11, GAMP5, and relevant internal quality standards.
Maintain accurate and thorough documentation of all validation and qualification activities.
Collaborate with
cross-functional teams
(IT, QA, Manufacturing, Business) to gather requirements and support validation project execution.
Participate in audits and inspections by regulatory authorities or clients as needed.
Contributes to the
continuous improvement
of validation processes and templates.
Required Qualifications:
Bachelor’s degree in engineering, Life Sciences, Computer Science, or related field.
1–5 years of experience in validation within pharmaceutical, biotechnology, or medical device industries.
Working knowledge of Gx P regulations, FDA 21 CFR Part 11, and validation lifecycle.
Familiarity with validation of laboratory instruments, ERP systems, LIMS, MES, or QMS applications is a plus.
Strong analytical and documentation skills.
Excellent verbal and written
communication skills
.
Ability to work independently and in a
team-oriented
environment.
Preferred Skills:
Experience with
Computer System Validation (CSV) and/or Computer Software Assurance (CSA) approaches.
Exposure to tools such as Veeva Vault, Master Control, Lab Ware, Empower, or SAP.Understanding of risk-based validation methodologies.
Title: Validation engineer – life science
Company: Master Compliance
Location: Medolla, Emilia-Romagna, Italy
Category: Engineering (Quality Engineering, Pharma Engineer), Quality Assurance – QA/QC (Quality Engineering)
