Pharmaceutical Validation Analyst

SIRE LIFE SCIENCES; Boxmeer; On-site; EUR 60,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES, based in Boxmeer, is seeking an experienced Senior Validation Specialist to lead sterilization process validation with a focus on filtration methods. The role involves investigating and improving filtration procedures to ensure GMP-compliant sterilization.

It is a project-based position emphasizing process enhancement and quality assurance. The ideal candidate will have substantial experience in pharmaceutical validation and strong GMP knowledge, with fluency in English.

Qualifications

• Minimum of 5–6 years of experience in pharmaceutical process validation and sterilization.
• Strong knowledge of GMP regulations, filtration processes, and the chemistry of aqueous and oily solutions.
• Proven experience in drafting protocols, reports, and validation documentation.
• Fluent in English; knowledge of Dutch is beneficial but not essential.

Responsibilities

• Lead the validation of sterilization processes, focusing on filtration methods.
• Investigate existing filters and filtration procedures to identify deficiencies and develop improvements.
• Modify filtration processes to meet strict sterilization standards.
• Write protocols, validation statements, and detailed reports in accordance with GMP guidelines.
• Collaborate with cross-functional teams to ensure process compliance and effectiveness.
• Document validation activities thoroughly and clearly.

Skills

Process validation

GMP knowledge

Filtration methods

Documentation

English

Cross-functional collaboration

Job description

Company

A leading pharmaceutical organization dedicated to producing sterile medicines through advanced manufacturing processes. The company specialises in mixing antigens and oils in large-scale vessels, ensuring the highest standards of product safety and quality.

Job Description

We are seeking an experienced Senior Validation Specialist to join the team in Boxmeer. This role is focused on the validation of sterilization processes, specifically investigating and improving filtration methods to ensure compliance with sterilization requirements. This is a project-based position with an emphasis on process enhancement and quality assurance.

Responsibilities

• Lead the validation of sterilization processes, focusing on filtration methods.
• Investigate existing filters and filtration procedures to identify deficiencies and develop improvements.
• Modify filtration processes to meet strict sterilization standards.
• Write protocols, validation statements, and detailed reports in accordance with GMP guidelines.
• Collaborate with cross-functional teams to ensure process compliance and effectiveness.
• Document validation activities thoroughly and clearly.

Requirements

• Minimum of 5–6 years’ experience in the pharmaceutical industry, particularly in process validation and sterilization.
• Strong knowledge of GMP regulations, filtration processes, and the chemistry of aqueous and oily solutions.
• Proven experience in drafting protocols, reports, and validation documentation.
• Fluent in English; knowledge of Dutch is beneficial but not essential.