Documentation Engineer

Start Date
: ASAP

Time commitment
: 42 hours per week

Title
:
Documentation Engineer

Description
:
Our client is currently finishing a CAPEX project and is currently in the Performance Qualification (PQ) Phase and preparing for production. They are therefore looking for a multitask CAPEX documentation engineer to support the technical teams in the preparation of text documents and technical documentation. Tasks may include but are not limited to:

• Performing Commissioning and qualification tests on the machines and equipment
• Take full ownership of the review and draft of the technical documents from the beginning until the end
• Draft and review URS, qualification plans, maintenance plans, risk assessment documents in compliance with GMP standards
• Cross-functional collaboration with other departments for the review and approval of the technical documentation (Quality Assurance, Safety, Maintenance, Engineering and Regulatory Departments)
• Act as technical support for the User Department
• Review P&IDs and potential non-conformances related to the Lyophilization field

• Years of experience: 3 to 10 years of experience (emphasis on soft skills and less technical skills)
• Strong technical documentation and strong GMP compliance skills
• Strong communication skills and willingness/motivation to bring the project from the beginning until the end
• Strong team-oriented person who will communicate and engage with all the departments
• Background in lyophilization or biological synthesis