Extractables & Leachables Validation Specialist

Company: Our client is a global organisation operating in a highly regulated life sciences environment. The site in Boxmeer supports manufacturing activities that must meet strict quality and compliance standards. Teams work closely across functions and internationally to ensure products are made safely, consistently, and in line with current regulations.

Job Description: Our client is looking for an Extractables & Leachables Validation Specialist (Sterile Filtration). This person will support sterile filtration activities by carrying out extractables and leachables (E&L) risk assessments and helping to complete sterile filter validation work. The role combines scientific assessment, strong documentation, and collaboration with both local colleagues and a global packaging team.

Responsibilities: Execute extractables and leachables (E&L) risk assessments to support sterile filtration activities within the manufacturing operation. Work closely with filtration colleagues on-site to support sterile filter validation activities. Collaborate with a global packaging team to align work with agreed standards and ways of working. Prepare, review, and maintain technical documentation, such as protocols, SOPs, deviations, CAPAs supporting assessments and evaluations.

Contribute to solving technical and quality-related issues through structured problem-solving. Support planning and coordination to ensure activities are completed within agreed timelines.

Requirements: Bachelor’s, Master’s, or higher degree in Biology, Chemistry, Pharmacy, or a related scientific discipline. Relevant experience in the pharmaceutical industry and understanding of quality requirements. Experience producing GMP-related documentation (e.g., SOPs, protocols, deviations, CAPAs, assessments). Practical experience executing E&L risk assessments. Strong organisational skills and attention to detail, with the ability to manage multiple tasks.

Comfortable working independently as well as in multi-functional teams. Business-level English. Able to work at a reasonable commuting distance from Boxmeer.

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