Equipment Validation Specialist

Location: Haarlem, Noord-Holland  |  Sector: Pharmaceuticals  |  Start Date: 5/14/2024  |  Job ref: 52695

The Company
Our client is one of the global leaders in biopharmaceuticals and generics with the drive to provide quality medicines to improve the lives of patients all over the world. With over 100 years of experience in the field, they have curated a wide range of pharmaceutical products used by millions every day.
  

Role description
The Equipment Validation Specialist supervises all analytical testing needed for manufacturing Cytotoxic and Inhalation medications. This involves performing a wide array of tests on active pharmaceutical ingredients (APIs), excipients, packaging materials, and final drug products to guarantee their quality and stability. Diverse analytical methods like Gas Chromatography (GC), Ultra-Performance Fourier transform infrared spectroscopy (FT-IR), and Ultraviolet-Visible spectroscopy (UV-VIS) are utilized for these evaluations.

Responsibilities

  • Assess, validate (including qualification), and incorporate cutting-edge, computerized laboratory apparatus (e.g., Gas Chromatography, Ultra-Performance Liquid Chromatography/High-Performance Liquid Chromatography, Fourier transform infrared spectroscopy, and Ultraviolet-Visible spectroscopy).
  • Guarantee on-time validation documentation completion, including managing contractor tasks.
  • Inform stakeholders and senior leadership about project progress.
  • Create training resources, calibration timetables, maintenance protocols, operational guidelines, equipment specifications, and a range of reports (e.g., User Requirement Specifications, risk assessments, Installation Qualification/Operational Qualification/Performance Qualification).

Requirements

  • Bachelor’s degree (HBO) in Chemistry or a related field required as a minimum qualification.
  • Extensive understanding of laboratory equipment, encompassing calibration, qualification, and validation.
  • 4-5 years of experience in the pharmaceutical industry or a similar GMP environment, with a minimum of 1 year dedicated to laboratory equipment validation.
  • Proficiency in written English essential for document creation.

Other
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

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