Validation engineer
Thermo Fisher Scientific
16 dagen geleden

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location / Division Specific Information

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.

How will you make an impact?

As part of the Validation Strategy and aligned with the Validation Master plan, to plan, develop and execute Validation activities and processes in order to support the commercial and manufacturing activities in Thermo Fisher Scientific Groningen, within regulatory & corporate requirements and guidelines, in order to achieve financial, business and strategic objectives as stated in the strategic plans.

What will you do?

  • Responsible for performing Validation activities mainly related to computer systems (CSV), with responsibility for results on Safety, Quality, and Quantity :
  • Responsible for achieving targets and standards in Validation;
  • Responsible for achieving priorities in the planning of actions and resources;
  • Responsible for achieving assigned and / or agreed departmental goals;
  • Measure the output and report results, deviations and issues.
  • Responsible for achieving the Validation Master Plan for Thermo Fisher Scientific Groningen in line with business needs and strategy :
  • Participate in achieving (some of the) strategic goals set for the department, which are in line with the corporate goals;
  • Participate in achieving the yearly plans of the department;
  • Support for (part of) the yearly cost budget for the department;
  • Support investment proposals for the department, manage investments;
  • Participate in cost reduction in fixed costs within the department;
  • Participate in cost consciousness in variable cost within the department;
  • Monitoring of the Key Operating Parameters of the department, when required.
  • Be a role model for the Validation systems and policies for the whole Thermo Fisher Scientific Groningen site;
  • Monitor external technological, legal and regulatory developments in the area of Validation and assess their applicability to and consequences for Thermo Fisher Scientific Groningen Site;
  • Responsible for continuous improvement in costs and results within validation activities;
  • Responsible for EH&S in Validation activities :
  • Responsible for creating and maintaining a safe and healthy working environment;
  • Ensure that activities at Thermo Fisher Scientific Groningen are within the EH&S requirements;
  • Ensure that activities in the department are within regulatory requirements (EMEA / FDA guidelines for manufacturing);
  • Foster the awareness for EH&S and Quality within Thermo Fisher Scientific Groningen.
  • Act according Thermo Fisher Scientific Corporate and Thermo Fisher Scientific guidelines, systems, and requirements;
  • Responsible for managing and coaching contractors :
  • Manage contractors that meets current and future requirements in terms of quality and quantity in order to establish and maintain cGMP compliance.
  • Education

  • BSc or Msc or equivalent level through education, training, and experience in Validation, Engineering, and / or Chemical Technology;
  • Experience

  • At least 5 years’ experience in a CSV Validation role
  • Experienced in any or all of the areas of responsibility; Validation, Reliability, and / or Engineering;
  • Experienced in a Biotech / Biopharma / cGMP environment.
  • Knowledge, Skills, Abilities

  • Excellent knowledge of instrument, equipment and computerized systems validation, pharmaceutical cGMP systems and international cGMP regulations and guidelines.
  • 21CFRPart11
  • Data IntegrityGood command of English, both in oral and written communication;
  • Excellent Knowledge and experience in EH&S;
  • Excellent Knowledge and experience in facilities for manufacturing of biologics
  • Good leadership and coaching skills;
  • Good communication and social skills;
  • Good presentation skills;
  • Excellent planning and organization sk ills
  • At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

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