Process & Cleaning Validation Specialist I

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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description Evaluate manufacturing process documents or equipment cleaning procedures that must be subjected to validation, in order to acquire information for the definition of the protocols and the execution of the process (both for product manufacturing and aseptic filling (Media fill)) and the cleaning validation of the procedures. Ensure periodic cleaning verification, as per SOPs and regulatory requirements. Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation and aseptic fillings (Media Fill). Ensure the drafting and/or updating of risk assessments for management of Cross Contamination. Ensure alignment with internal SOPs, through verification and supervision of the application of procedures of the areas of competence. Validate the manufacturing processes (applying "Lifecycle approach" Stage 2 Process Qualification and Stage 3 Continued Process Verification), cleaning procedures and APS/Media Fill, collaborating with other departments in the operational activities envisaged by the Protocols. Support, in conjunction with other functions, in the drafting and approval of documents relating to new products in the transfer and validation phase. Handle deviations related to validation activities if necessary. Ensure accurate execution of validation activities, through the accurate collection and accurate analysis of the results generated. Draft the Validation Reports, based on the results emerging from the validation activities. Ensure the accurate archiving of all documentation. Provide quality support for the transfer of new products, through accurate participation in the various phases of the project up process performance qualification, assuring accurate GMP standards in force. Actively participating as SME in all design, construction and implementation phases of new processes or manufacturing departments. Additional tasks could be requested to support other Departments in accordance to indications received by the Management.

Education

• Completion of a Bachelor's Degree or its equivalent (depending on country) in a scientific/pharmaceutical area (FCT, Pharmacy, Chemistry, Biotechnology)

Technical skills

• Pharmaceutical techniques
• Pharmaceutical production
• Aseptic Filling processes
• Risk management
• Client service/ Project Management experience
• Knowledge of Microsoft Office software (i.e. word, Excel)

Professional Experience

• Previous direct experience in Process Validation, Cleaning Validation, Aseptic Process Simulation (at least 1 year is preferable) for Sterile Products.
• Equivalent combinations of education, training, and relevant work experience may be considered (i.e. Manufactruing Technology)

Languages

• Italian as basice and English : Advanced written and oral communication skills

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.