Job Description
• Develop test plans and protocols for commissioning and validation.
• Lead commissioning within assigned areas, including equipment inspections, field verification walk-downs and commissioning test execution.
• Provide equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of equipment installation manuals (EIM).
• Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management.
• Provide process engineering input during design development, construction, testing, commissioning and validation, and help manage changes through the project.
• Review and approve process engineering specifications, including process piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for new equipment and systems.
• Review and approve equipment vendor submittals, including system piping layouts, general arrangements and other equipment specifications and drawings.
• Lead the turnover of systems for subsequent validation activities and provide technical support throughout validation activities.
• Understand and implement internal policies, procedures and specifications as required for the execution of process engineering for the project.
• Interface with stakeholders to ensure the design, execution and delivery are in accordance with Global Engineering, Quality, Environmental and Safety procedures.
Qualifications
• A first strong experience in engineering, construction, commissioning and validation in a GMP/ pharmaceutical / biotech manufacturing environment, or an equivalent combination of education and experience
• A first experience in working with Automation Design Documents (Equipment Modules, Phases and Recipes Functional…)
• You are familiar with the cleaning guidelines of ASME BPE for piping and sprayballs
• English required, and fluency in German or French or Italian preferred.
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Education
• Bachelor’s or master’s degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing Advanced degree strongly preferred First experience in the biotechnology/ pharmaceutical production