Validation Specialist: Process & Cleaning (Sterile)

ThermoFisher Scientific; Ferentino; On-site; EUR 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Validation Specialist to evaluate manufacturing process documents and cleaning procedures, define validation protocols, and support aseptic filling activities. The role involves cross-department collaboration to ensure regulatory compliance and accurate documentation.

The candidate will draft validation protocols, perform risk assessments for contamination, and verify processes per SOPs, contributing to lifecycle qualification and transfer of new products.

Qualifications

• Bachelor's degree or equivalent in a scientific/pharmaceutical area.
• Experience in Process Validation, Cleaning Validation or Aseptic Process Simulation preferred.
• Italian base language with advanced English written and spoken communication.

Responsibilities

• Evaluate manufacturing process documents or cleaning procedures to define validation protocols.
• Draft Validation Protocols (cleaning, Process, Media Fill) by collecting information from other departments.
• Handle periodic cleaning validation and aseptic fillings (Media Fill).
• Ensure drafting and updating risk assessments for cross contamination and align with SOPs.
• Validate manufacturing processes, cleaning procedures and APS/Media Fill with Lifecycle approach.
• Draft and archive validation reports and provide quality support for product transfers and new products.
• Act as SME during design, construction and implementation of new processes or departments.

Skills

Pharmaceutical techniques

Pharmaceutical production

Aseptic Filling processes

Risk management

Client service/ Project Management

Microsoft Office (Word, Excel)

Education

Bachelor's degree in a scientific/pharmaceutical field

Tools

Microsoft Office

Job description

Thermo Fisher Scientific is seeking a Validation Specialist to evaluate manufacturing process documents and cleaning procedures, define validation protocols, and support aseptic filling activities. The role involves cross-department collaboration to ensure regulatory compliance and accurate documentation.

The candidate will draft validation protocols, perform risk assessments for contamination, and verify processes per SOPs, contributing to lifecycle qualification and transfer of new products.