Senior Specialist, Quality Engineering
Bristol-Myers Squibb
Leiden – NL
3 dagen geleden

Bristol Myers Squibb Netherlands Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands.

This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing.

You can become part of this exciting journey. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea.

As we continue to expand our footprint by building this new site, we are looking to grow our team. Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer?

Join us and be a game changer! For more information about Bristol Myers Squibb Netherlands, visit us at or Purpose and Scope of the position The Quality Engineering (QE) team is responsible for providing Quality leadership, oversight and governance primarily to technical elements topics in the Leiden (Netherlands) Cell Therapy manufacturing facility.

The Senior Specialist, Quality Engineering is responsible for providing support, oversight and governance primarily to technical elements topics in the Leiden (Netherlands) Cell Therapy manufacturing facility, providing expertise and leadership to an extent in establishing processes and ways of working.

Also provides appropriate level of expertise and judgement to other functions related to activities the QE team is representing Quality for.

Duties and Responsibilities Support all activities for the Quality Operations Engineering group. Support the Commissioning, Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.

Assure appropriateness of calibration / maintenance programs, validation plans, qualification protocols, associated reports and procedures.

Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Commissioning / Qualification and Validation teams.

Includes Quality input and oversight to fundamental facility start-up activities such as environmental monitoring performance qualification, utility qualification, and aseptic (or media) process simulation / validation.

Ensure site is compliant with global / corporate and regulatory data governance and data integrity requirements, by establishing and maintaining compliant procedures and processes.

Provide Quality oversight of manufacturing process transfers and validation, as well as QC analytical method transfer and validation, in compliance with company and regulatory requirements.

Effectively interact and communicate internally within the Quality Engineering function and with internal and external partners and cross-functional teams.

Represents department in internal and external cross-functional teams. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

Employees holding this position will be required to perform any other job-related duties as requested by management. Requirements and Competencies Relevant university degree preferred.

Minimum of 5 years of relevant experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.

Knowledge of, and relevant experience with GMP, Quality, and pharmaceutical risk management. Ability to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.

Have capability for managing development of technical or scientific initiatives and activities by interdisciplinary teams.

Capability for effective verbal or written communication in support of all required competencies and responsibilities. Have strong authorship and ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.

Have capability to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.

  • Requires minimal direction to completion of assigned tasks, demonstrates capability for getting resources and information from established internal contacts;
  • consults with supervisor for decisions outside established processes Capability for providing effective written or verbal guidance to other employees in the interpretation of technical / scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams Proven capability to recognize and resolve Quality issues, and effectively communicate proposed solutions to Management, or escalate complex issues in a manner to facilitate effective guidance.

    Able to fully interpret complex results and situations with degree of independence and verbally articulate or provide effective written recommendations for solutions, or develop contingency plans when risks are recognized.

    Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

    Demonstrated as action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

    Has experience and knowledge to enable recognition as a Subject Matter Expert within the Quality Engineering team. Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

    Able to write and review reports with clarity and brevity. Able to produce data reports with precision. Around the world, we are passionate about making an impact on the lives of patients with serious diseases.

    Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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