Nederland, Boxmeer
Ervaring: N.v.t.
Opleiding: Hbo
Life Sciences
Uiterlijke sollicitatiedatum: 30 mei 2025

Solliciteren

Introductie

You will be working within the Center of Excellence Quality Operations in Boxmeer, while being part of the global Packaging Center of Excellence. In this role, you will primarily support sterile filtration validation by performing Extractables & Leachables (E&L) risk assessments in accordance with EU GMP Annex 1. You will work closely with the Filtration team in Boxmeer and receive training and support from the global Packaging CoE.

Functieomschrijving

As an E&L Specialist, you will work within the Center of Excellence (CoE) Quality Operations in Boxmeer, while being an integral part of the global Packaging CoE. Your primary responsibility will be to support the validation of sterile filtration systems by executing Extractables & Leachables (E&L) risk assessments in alignment with EU GMP Annex 1 guidelines. You will collaborate closely with the local Filtration team and receive full training and support from the global Packaging CoE team.

Key Responsibilities:

  • Perform risk assessments related to Extractables & Leachables (E&L) for sterile filtration processes.
  • Ensure all assessments are in compliance with EU GMP Annex 1 regulations.
  • Collaborate with cross-functional teams including Quality, Filtration, and Global Packaging CoE.
  • Contribute to documentation such as SOPs, protocols, and technical reports according to GMP standards.
  • Occasionally support other projects within the Global Packaging CoE scope.

Vereisten

  • Bachelor's, Master's, or PhD in Biology, Chemistry, Pharmacy, or related scientific discipline.
  • Experience in the pharmaceutical industry, with a strong understanding of GMP and regulatory requirements.
  • Proven experience with technical writing (SOPs, protocols, deviations, CAPAs, risk assessments).
  • Strong analytical, problem-solving, and project management skills.
  • Ability to work independently and within cross-functional teams.
  • Excellent communication skills in English (spoken and written).
  • Detail-oriented, organized, and capable of managing multiple tasks and deadlines.
  • Based within reasonable commuting distance to Boxmeer.

Arbeidsvoorwaarden

What you can expect:

  • A gross monthly salary €4500- €6500 excluding 8% holiday allowance), depending on your experience
  • Optional bonuses
  • Additional benefits such as a lease car, travel allowance, public transport card, iPhone, or laptop
  • 26 vacation days, with the option to extend
  • Extensive training and career development opportunities, including access to the Brunel Academy
  • A solid pension plan and collective health insurance
  • Discounts on gyms, cultural activities, and well-being programs

About Brunel Brunel provides both flexible and permanent staffing solutions to leading companies in the technical sector. Brunel Engineering specializes in seconding both entry-level and experienced engineers across a wide range of disciplines.

Contactgegevens vacature

LK

Lisette Koopman

+31 20 312 5000