Our client, who is an international pharmaceutical, is looking for a Process Engineer (40 hours) in Amsterdam area.
All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.
We are seeking a highly motivated Process Engineer to represent Manufacturing - Site Manufacturing Technology (SMT) in the project team. Our client is establishing a project team dedicated to implementation of MES (Manufacturing Execution System) and EBR (electronic batch record) at the manufacturing site.
The project is coordinated globally and therefore collaboration with US (West-Coast) colleagues is required. Therefore, flexibility in terms of working hours might be required.
- Participate in the design and implementation of electronic batch records within a Manufacturing Execution System (MES)
- Provide front line technical support for manufacturing during MES engineering and validation runs
- In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of project related deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.
- Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
- Trends key performance metrics
- Conducts technical training and guidance to the CTS
- BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 4+ years of relevant industry experience or MS with 2+ years of relevant industry experience
- Cell therapy, cell culture and/or aseptic processing experience
- Broad knowledge of cGMP compliance and experience with leading investigations, deviation reports, change controls, and assignment of corrective actions
- Experience with root cause analysis tools and proficiency in Quality Systems
- Possess strong communication and technical writing skills
- Experience leading cross functional teams to achieve 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
- Knowledge of manufacturing execution systems (MES), Werum PAS|X, is desirable
What do we offer
- Contract via Kelly Services
- Start date: ASAP
- Salary indication depending on experience
Please do contact Marcella Henryati, Recruitment Consultant
When interested please apply with your English resume on our website: www.kellyservices.nl
About Kelly Services
It's more than a job. It's passion. Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.