Documentation engineer

Job description

We are now seeking a skilled and detail-oriented Documentation Engineer for our client.

This is an exciting opportunity to work in a dynamic environment and contribute to the creation of clear, concise, and accurate technical documentation.

Responsibilities

• Key delivery is to review specifications for equipment with automated systems and establish good process knowledge to enable regular manufacturing in a GMP environment.
• Support the process lead with process equipment knowledge in general but specifically for automated systems and user interfaces
• Train and educate operational personnel in the use of the systems
• Develop documentation package to complete the delivery to the receiving organization
• Establish asset management with Engineering organization
• Contribute in the design of the future process and equipment ensuring word class operation.
• Work according to developed validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols, and other relevant documents.

Qualifications

• Long experience pharmaceutical manufacturing
• Experience in process development, improvement and optimization
• Good knowledge in the operational environment.
• Experience in process and production equipment.
• Knowledge of technical advanced machines (fully automated), vision systems, infrastructure and other relevant areas within operations
• Understanding in the process of verification and validation.
• Knowledge with pharmaceutical and medical device industry requirements (cGMPs, 21 CFR Part 11, GAMP5).

About the company

Randstad

At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential.

With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.