Senior Validation Engineer – Softgel GMP & Equipment

ThermoFisher Scientific; Tilburg; On-site; EUR 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific in Tilburg, Netherlands, is seeking a Validation Engineer to join the GMP-regulated validation team responsible for planning, executing, and documenting qualification activities across equipment, processes, cleaning, and computer validation.

You will draft URS with suppliers, lead validation deliverables for projects, provide technical support to other departments, and help maintain Validation Master Plan and compliance with current pharma regulations.

Qualifications

• Proven hands on experience in Commissioning and Validation gained preferably within a Pharmaceutical environment or equivalent that is a highly regulated environment
• Ability to review and extract information from systems and put together reports for Periodic Review
• Strong communication skills

Responsibilities

• Offers expertise for designing and qualifying new equipment and systems, changing existing processes and systems, expanding production, facility, and implementing new and transferred products.
• Co-drafts User Requirement Specifications (URS) within a multi-functional team and with suppliers.
• Drafts and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment, utility, processes, cleaning, and computer validation, including reports and advice regarding periodical review frequencies.
• Writes cleaning validation and Continued Process Verification (CPV) protocols.
• Writes periodic validation reports for critical equipment/utilities/processes, including Continued Process Verification (CPV).
• Provides validation technical support within other departments.
• Drafts, reviews, and amends procedures, Validation Master Plan, and other audited documents.
• Remains abreast of the current developments and regulations for the pharmaceutical industry.
• Validation of SME for internal and external audits.
• Ensures the validated status of all cGMP-critical automated process applications and quality systems.

Skills

Commissioning & Validation

Technical report writing

Strong communication

Job description

Thermo Fisher Scientific in Tilburg, Netherlands, is seeking a Validation Engineer to join the GMP-regulated validation team responsible for planning, executing, and documenting qualification activities across equipment, processes, cleaning, and computer validation.

You will draft URS with suppliers, lead validation deliverables for projects, provide technical support to other departments, and help maintain Validation Master Plan and compliance with current pharma regulations.