Senior Process Engineer
Senior Process Engineer
Netherlands - Hoofddorp
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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. Kite 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.
The Senior Process Engineer is part of the Site Manufacturing Technology (SMT) team for the manufacturing site in Hoofddorp (NL). The Senior Process Engineer is 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.
- Lead, coach and coordinate front line technical support for manufacturing of cell therapy products
- Lead manufacturing Projects and Continuous Improvement Projects
- Cross-functional project Manufacturing representative.
- 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
- Other tasks and duties as assigned by Management
Knowledge, Experience and Skills:
- Minimum 7 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
- MSc in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent.
- Experience with investigation and root cause analysis tools
- Skilled at creating and delivering presentations
- Proficiency in Project leadership
- 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
- 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, pro-active, strategic forward thinking, 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.
- Able to work in shifts including weekend shifts and/or be able to work on-Call / On stand-by outside office hours
Please submit a 1-page letter of motivation along with your CV.
As part of our recruitment process, you will be asked to complete a short 20-minute online Occupational Personality Questionnaire (OPQ) and/or a capability test.
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 Current Gilead Employees and Contractors:
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