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Manufacturing Process Engineer

Posted 25 Mar 2024
Work experience
5 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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Job Description

Under minimal supervision, this position’s main accountabilities are focused on the front line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.

Kite, a Gilead Company

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.

Kite Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. We’re building a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp). 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.

Department Description

As Manufacturing Process Engineer, you’ll be joining a newly formed team, in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the Senior Manager Site Manufacturing Technology (SMT).

You’ll be part of the SMT team for the new to build manufacturing site in Hoofddorp (NL). In this role you will be part of the technical team, responsible for supporting deviations, CAPAs, change control and front line support for Kite’s commercial manufacturing site producing autologous T cell therapy products.

Your responsibilities

  • Provide front line technical support for manufacturing of cell therapy products
  • Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues
  • Partner with Product Sciences Team
  • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.
  • Issues and implements CAPAs to address root cause and ensure effectiveness
  • Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
  • Trends key performance metrics
  • Participates in internal audit/inspection
  • Represents Manufacturing operations in Change Control, CAPA and Deviation meetings
  • Conducts technical training and guidance to the Cell Therapy Specialists
  • Other tasks and duties as assigned by Management

Your profile

Education

  • BSc in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent.

Knowledge and Experience

  • Minimum 5 years of experience including cell culture and/or aseptic processing
  • Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
  • Experience with investigation and root cause analysis tools
  • Skilled at creating and delivering presentations
  • Proficiency in Quality systems
  • Utilizes technical writing strategies to ensure content is clear and concise
  • Possesses good communication skills
  • Experience leading cross functional teams to obtain project deliverables
  • Working knowledge of scientific and engineering principles
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

Personal skills

  • Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
  • Collaborate well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel.
  • Ability to think critically and demonstrated troubleshooting and problem solving skills.

Additional Requirements

  • Ideal to have start-up experience as the fast paced environment experience will match Kite's environment
  • Flexibility to working in shifts including weekend shifts
  • If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us.

Apply now!

Only candidates in possession of a valid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

#LI-WK1

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For the past three decades, members of our team have been at the forefront of cancer immunotherapy. Today, we are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago.

Pharmaceutical
Hoofddorp
2,000 employees