Validation Specialist – Sterilization Processes

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 65,000 - 85,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a skilled Validation Specialist to support the validation of sterilization processes in Boxmeer, NL. This project-based role focuses on ensuring filtration and sterilization methods meet strict industry standards and GMP guidelines.

You will investigate and optimize filtration techniques, write validation protocols and reports, and collaborate with cross-functional teams on-site to implement process improvements and ensure quality and compliance throughout the

Qualifications

• Minimum of 5–6 years of experience in the pharmaceutical sector.
• Proven experience in writing protocols, validation reports, and technical documentation.
• Strong knowledge of GMP regulations, sterilization, and filtration processes.
• Solid understanding of the chemistry of aqueous and oily solutions.
• Excellent communication skills in English; familiarity with Dutch is a plus but not required.

Responsibilities

• Investigate existing filtration processes used during sterilization.
• Modify and improve filtration methods to ensure they meet sterilization requirements.
• Write validation protocols, reports, and statements to document findings and procedures.
• Collaborate with cross-functional teams on-site to implement process modifications.
• Ensure all activities comply with GMP guidelines and quality standards.
• Support validation activities from initial assessment through to final implementation.

Skills

Written protocols

GMP knowledge

Technical documentation

Job description

Overview

Company Overview: A leading pharmaceutical organization focused on the production of sterile medicines. They operate state-of-the-art facilities and are committed to maintaining the highest standards of quality and safety in their products.

Job Description

Job Description: We are seeking a skilled Validation Specialist to support the validation of sterilization processes. This is a project-based role based in Boxmeer, designed to ensure that filtration and sterilization methods meet strict industry standards. The successful candidate will play a vital part in investigating and optimizing filtration techniques to address current challenges with filter performance.

Responsibilities

• Investigate existing filtration processes used during sterilization.
• Modify and improve filtration methods to ensure they meet sterilization requirements.
• Write validation protocols, reports, and statements to document findings and procedures.
• Collaborate with cross-functional teams on-site to implement process modifications.
• Ensure all activities comply with GMP guidelines and quality standards.
• Support validation activities from initial assessment through to final implementation.

Qualifications

• Minimum of 5–6 years of experience in the pharmaceutical sector.
• Proven experience in writing protocols, validation reports, and technical documentation.
• Strong knowledge of GMP regulations, sterilization, and filtration processes.
• Solid understanding of the chemistry of aqueous and oily solutions.
• Excellent communication skills in English; familiarity with Dutch is a plus but not required.

Other Information

If you are interested and want to apply, please submit your application via the apply button below and contact me.