Vacancy Laboratory Equipment Specialist – Haarlem


Organization

05 SEPT ’22:For a global pharmaceutical leader, we are currently looking for a Lab Equipment Specialist. They offer a uniquely diverse portfolio of products and solutions for patients and they’ve built a promising pipeline around their core therapeutic areas. They continually develop patient-centric solutions and significantly grow both their generic and speciality medicines business through investment in R&D, marketing, business development and innovation.

Function

The Quality Analytical Laboratory is responsible for all analytical testing to support the production of Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test packages to test APIs, excipients, packaging materials and drug products for release and stability purposes. The department is also responsible for transferring, validating, and verifying analytical methods for testing new drug products. A variety of analytical techniques is used a.o. GC, UPLC/HPLC, UV, FT-IR and UV-VIS. In order to expand and strengthen this responsibility, the Quality Analytical Laboratory is searching for a Laboratory equipment specialist.

The responsibilities include assessing, qualifying (incl. validation) and implementing sophisticated high-end (computerised) Laboratory equipment and determining priorities within own project while keeping track of project execution across multiple departments. You will oversee the timely completion of all validation documentation, including coordination of contractor activities and support the regulatory defence of validation protocols and summary reports during audits and internal audits.Other responsibilities include:

  • Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations;
  • Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems;
  • Present project status to stakeholders and (senior) management;
  • Write training instructions, calibration, maintenance, operational procedures, equipment specification files and reports ((URS, Risk assessments, IQ/OQ/PQ);
  • Fulfil the role of a Subject Matter Expert and participate actively during audits;
  • Being a person of contact between suppliers and the laboratory;
  • Manage contracts for maintenance and/or calibration and computerised systems and applicable software;
  • Develop Validation Master Plans, Validation Project Plans and Project Schedules as needed.

Requirements

The requirements for this role are experience in the pharmaceutical industry or an equivalent GMP environment for 4-5 years with at least 1 year of experience in the validation of laboratory equipment. You will support laboratory investigations as an equipment SME, so you also have experience with scientific analytical approaches and good knowledge of laboratory equipment with experience in calibration, qualification, and validation.

  • A bachelor’s or master’s degree with a technical background and an interest in the IT environment;
  • Experience with deviations, changes and CAPA writing;
  • Organisational capabilities are part of your nature;
  • Team player with sound communication skills, and a proactive approach;
  • Good problem-solving skills.

Offer

The organisation can offer you a base annual salary between EUR 42.000 – 60.000 based on experience.Furthermore, you’ll get an 8% performance bonus and a 5,3% Personal Choice Budget. You’ll also get:

  • 25 vacation days;
  • 5% health insurance discount;
  • Excellent pension plan.


Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Eda Günes
Associate | Biotechnology & Pharmaceuticals

+31 6 10 46 76 39
+31 23 754 86 60
e.gunes@qtcrecruitment.com