Validation and Qualification Engineer

vor 4 Wochen

Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

Job Description:

Our Manufacturing & Supply Division aims to be the most reliable supplier of biopharmaceuticals globally. The facilities, along with contractors, suppliers, and partners, form a robust global manufacturing network dedicated to delivering top-notch products to customers and patients consistently on schedule.

Our Manufacturing Operations teams are the backbone of our product creation. We operate in manufacturing plants with a mindset of "Safety First, Quality Always", always striving for enhancement. We collaborate with the local plant, ensuring top-notch quality of raw materials, intermediates, and finished products as part of our global manufacturing network.

For our location in Krems, we are currently seeking a:

Validation and Qualification Engineer (m/f/d)

for a two-year contract, starting at your earliest availability

Main Responsibilities:

  • Leading assigned Commissioning, Qualification, and Validation (CQV) activities such as equipment, processes, cycles, sterilization, transport, etc.
  • Developing and approving CQV Plans and Reports.
  • Supporting equipment and systems owners with technical expertise.
  • Establishing and/or participating in risk analysis and assessment to bolster CQV activities and change management.
  • Backing Change Management, Deviation Management, and CAPA Management process on-site and ensuring timely task completion.
  • Adhering to GMP, company, and local safety and CQV regulations.
  • Potentially serving as a sub-system owner for qualification and validation topics.
  • Supporting the site's CQV program through reviews, requalifications, Sanitization/Sterilization in Place (SIP), and Performance Qualifications (PQs) among others.
  • Working collaboratively with a team and stakeholders to maintain the facility and equipment's qualified and validated status.
  • Initiating and supporting continuous improvement activities within CQV and the site.
  • Supporting the site in various Qualification and Validation aspects based on production needs during the two-year period.

Requirements:

  • Minimum 3 years of experience in large-scale production qualification and validation.
  • Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or relevant field.
  • Fluency in written and spoken German and English along with proficiency in MS-Office applications.
  • Experience in a Pharmaceutical Company, particularly in Aseptic Processing operations.
  • Hands-On-Experience or knowledge in CQV, (Bio) Process Technology, Microbiology, and Aseptic Processing Equipment Design.
  • Expertise in the qualification and validation of sterilization processes and aseptic media simulation.
  • Knowledge in risk management, change management, deviations, and CAPAs management.
  • Strong team player with strategic, analytical, and problem-solving skills.

We offer an attractive salary, outstanding social benefits, and a dynamic work environment with diverse tasks in an international setting. The minimum annual salary for this role is EUR 44.100,- and is subject to the candidate's qualifications and experience. We look forward to receiving your application.

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