Job Title: Validation Analyst / Validation Engineer

Experience Level: 1–5 Years

Location: Hechingen, Germany

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, GxP, 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 GxP-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 GxP 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, MasterControl, LabWare, Empower, or SAP.
• Understanding of risk-based validation methodologies.