Operations/Project Engineer Qualification in the field of Pharma Engineering Solida

Operations/Project Engineer Qualification in the field of Pharma Engineering Solida #

(m/f/d)

freelance/in temporary permanent employment for a project

Basel

Start date: immediately

Reference number: 885689/1

Tasks ###

• Execution and support of qualification activities in investment projects
• Creation and execution of qualification plans and reports
• Review of verification documents regarding GMP compliance and fulfillment of acceptance criteria
• Creation, tracking, and completion of qualification pending items
• Maintenance of inventory data for qualified equipment
• Partnership-based cooperation with various interfaces
• Presentation of qualification during inspections
• Answering inspection questions and maintenance of the contact partner matrix
• Estimation and assessment of the impact of changes and deviations on the qualified status and critical aspects
• Execution of (re-)qualification measures as a result of changes and deviations
• Planning and execution of periodic qualification reviews, approval of technical planning documents, and assumption of inventory responsibility

Profile ###

• Completed training / studies in one of the disciplines of automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology with sound professional experience in a GMP-regulated working environment
• Practical experience in the implementation of technical GMP requirements of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and in operations engineering
• Orderly, structured, and exact way of working, high social competence as well as strong teamwork skills
• Very good communication and coordination skills, also in dealing with stakeholders at all levels
• Openness and ability to actively contribute in a flat and agile organization
• Focus on the delivery of results with measurable added value for the business
• Quick comprehension as well as the ability to communicate complex matters understandably to customers or authorities
• Independent and autonomous processing of complex tasks
• Reliable implementation of agreed priorities
• Very good German and English skills

Benefits ###

• Long-term planned project duration in a global top 5 pharma company
• Exciting and innovative environment
• Appreciative and pleasant working atmosphere