Pracodawca zakończył zbieranie zgłoszeń na tę ofertę


Pracodawca zakończył zbieranie zgłoszeń na tę ofertę

Validation Engineer

Phillips Medisize

  • Siemianowice Śląskie

    Siemianowice Śląskie, Silesian
  • offer expired 3 months ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • full office work

Your responsibilities

  • Evaluate the validation requirements associated with a project or program.

  • Conduct and coordinate validation and qualification activities (applies to manufacturing processes, computerized systems, equipment, instrumentation, test methods and installations).

  • Preparation of validation documentation (protocols, reports) according to ISO 13485, FDA requirements and internal procedures (including statistical evaluation of results obtained during validation).

  • Identify risks and develop risk analyses.

  • Support the user in creating and updating documents (e.g. URS).

  • Support the team responsible for carrying out specific tasks during the validation process of machines, equipment and production processes.

  • Work with operations and client departments to ensure all systems are qualified and/or validated in accordance with regulations.

  • Analyze and escalate deviations detected during validation, propose CAPA actions.

  • Ensure that applicable requirements and procedures for validation activities are met.

  • Represent the area during internal and external audits.

  • Participate in change management and periodically review for revalidations.

  • Prepare and deliver training on validation and quality processes.

  • Create/co-operate in the creation of quality documentation for validation, administration of computerized systems.

  • Promoting and applying in practice company culture rules.

  • Segregating wastes systematically, minimizing the use of materials.

  • Compliance with the health, safety and fire regulation, procedures and instructions.

  • Adherence to documentation related to Quality Management System. - Perform other duties as assigned by supervisor.

Our requirements

  • University degree in chemistry, pharmacy or a related field.

  • Working experience in positions related to validation and/or quality processes.

  • Very good in spoken and written English, at B2 level.

  • Knowledge of validation and/or quality engineering issues in medical device manufacturing. Knowledge of: ISO 13485, GMP requirements, 21 CFR Part 11, 21 CFR 820, GAMP5, knowledge of conducting internal audits, quality tools.

  • Ability to read technical drawings.

  • Analytical thinking and problem solving.

  • Statistical approach to sampling and data analysis, plan execution and good organization of own work, accuracy, attention to detail, proactive approach to tasks and willing teamwork, initiative and commitment.

  • Skilled in managing large scale projects, developing and executing project schedules and creating contingency plans.

  • Effectively present information and respond to cross-functional questions.


  • Postgraduate studies in Enterprise Quality Management and validation topics.

  • Fluent in spoken and written English in daily work, at C1 level.

  • Knowledge of Lean manufacturing Six sigma methodologies.

  • Knowledge of SAP.

  • Knowledge of Minitab.

  • Decision-making skills.

What we offer

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Phillips Medisize

Who We Are As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

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