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Senior Quality Engineer

Netherlands - HoofddorpQualityRegular
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Job Description

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Job Description

As a Senior Quality Engineer you’ll be joining a team in which people of diverse backgrounds and experiences are respected, and are working together focused on saving lives by finding the cure for cancer. You will report to the Director Engineering of manufacturing plant in Hoofdorp (TCF04).

Your profile

  • Support enterprise, cross functional and local computer systems validation activities, in providing approach, methodology and deliverables in compliance with GMP, 21 CFR Part 11, EU Annex 11 and Data Integrity.

  • Provide Quality oversight, inputs and quality approvals for validation documents and help to ensure Quality, Data integrity and compliance of TCF04 IT/OAT systems.

  • Partners with and maintains alignment between IT/OAT (Operations Automation Technology) and BPQ's (Business Process Owner) and end users for the delivery and maintenance of IT systems/automation for the site.

  • Reviews and approves documents, change controls, and protocols related to IT/OAT systems (site and global).

  • Ensures the application of data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.

  • Represents Quality for TCF04 throughout the initiation and implementation of projects related to electronic systems/automation.

  • Support risk-based approach to qualification of enterprise and computer systems.

  • Ensure that GMP computer systems meet intended uses and comply with applicable regulations, current industry practices, and Kite policies and procedures. CSV projects will include manufacturing and lab systems, and steady state activities around these systems and its applications.

  • Develop validation documents (Validation plan, Qualification and UAT plans and test cases, Traceability Matrix and Validation Summary Reports) with functional teams, ensuring the documentation meets compliance requirements and quality standards.

  • Act as the Quality Reviewer/Approver for validation activities (GxP-IT/CSV).

  • Drive continuous process improvement in the area of computer system validation.

Your new role

  • BSc degree in Engineering, Computer Science to relevant scientific field.

  • Previous experience in FDA/EU regulated environment with good understanding of GxP standards, Risk based validation and cGMP manufacturing for biotech/pharmaceuticals.

  • Knowledge of EU and FDA guidance’s, regulatory regulations and industry standards on computerized systems in pharmaceutical industry
    (i.e. Quality Systems, GAMP5, 21CFRPart11 and EudraLex Volume 4 Annex 11).

  • Experience with the creation, review, and execution of qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations. Experience with Computer System Assurance (CSA) in CSV is  plus (is it not a must to have?)

  • Experience with electronic validation software (e.g. Valgenesis, HPALM, KNEAT) is a plus

Your soft skills

  • Ability to think critically and utilize troubleshooting and problem-solving skills.

  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.

  • Well-developed computer skills and fluent with Microsoft office applications.

  • Excellent interpersonal, verbal and written communication skills and ability to work in collaborative and fast paced work environment.

  • Comfortable in a fast-paced company and ambiguous environment