Automation Projects support

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce

We are currently looking for an Automation Projects support for 1 year + possible extension.

Main tasks:
Assist the Senior Engineer in CAPEX projects: under his general supervision, this position will perform and assist technical work, provide engineering and design services, and/or develops concepts, designs and details.

· Preparation, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment) focus on, but not limited to, CSV for new systems in collaboration with internal and external partner
· Support for Change Control creation and tracking of defined action items
· Contribution to ensure that changes to systems, procedures, processes and formulas are appropriately managed such that resulting impact on equipment / computerized systems commissioning and qualification process are assessed and resolved.
· Compilation of costs for CAPEX application (supplier quotations, and internal workload estimation)
· Management of all orders related to a project (delivery, delays, receipt, feedback)
· Organization of meetings and status reporting

Qualifications:
· Bachelor/Master's degree in technical or natural sciences
· A minimum of 3 years of working experience
· Experience in the pharmaceutical industry and GMP
· Know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines
· Technical understanding of the function of equipment and understanding of the offers and needs of the departments (Qualification, Engineering, Production)
· Sound experience with various IT-tools, systems, especially MS
· Excellent communication skills
· Business fluency in German and English
· Understanding of automation related topics is a plus
· Understanding of finance and cost control is a plus
· Quick learning ability and shown hands-on mentality

If you are interested in hearing more about our Automation Projects support role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!