Job description

We are seeking an experienced Commissioning, Qualification, & Verification  lead Engineer!

For Randstad, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Randstad Professional is the career partner that will help you find the right job, love what you do, and develop your career. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. With access to a wide range of roles with top employers, a global community of professional peers, and specialized training and support, we'll be your guiding partner and help you build a rewarding career.

Responsibilities

Key delivery is to support the process lead with strategies and actively lead the commissioning and qualification work forward in the project.

This includes a deep understanding of the equipment requirement specifications and bridge the gap from Project phase to Production phase.

The person shall also attend and lead the SAT/technical trials/traceability matrix so that we at the end have tested all requirements needed for qualification. This job will be assessed in close cooperation with the technical experts of the individual machines.

Take lead in the development of the validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols/reports, and other relevant documents.

Qualifications

• Experience in process and production equipment.
• Highly experienced in the process of verification and validation.
• Knowledge of technical advanced machines (fully automated), vision systems, infrastructure and other relevant areas within operations.
• Knowledge with pharmaceutical and medical device industry requirements (cGMPs, 21 CFR Part 11, GAMP5, Medical Device Regulation, ISO 13485, ISO 14971).
• 5-8 years Experience of Commissioning, Qualification, & Verification 
• experience leading a team of engineers working on downstream processes of manufacturing is important

• Great communication skills
• Strong coordination and coordination skills, and well structured
• Critical thinker with problem-solving skills
• Team player
• Fluent in English.
• Bachelor’s Degree in Engineering or equivalent experience/qualification

About the company

Randstad