Senior Process Engineer

The Company: Our client is a global health care company that delivers innovative health solutions through its prescription medicines, vaccines, biologic therapies, and animal health products. It`s first European branch opened in 1954 in Amsterdam and now has other facilities in the Netherlands serving more than 140 countries.

Role Description: The Senior Process Engineer will support the commissioning and qualification (C&Q) of a new small-molecule pharmaceutical manufacturing facility at the site in Boxmeer. The facility is designed for sterile suspended pharmaceutical products. The main responsibility is to lead the Performance Qualification (PQ) of new manufacturing assets, ensuring that equipment and processes meet the required standards. The engineer will also lead root cause investigations into equipment-related issues arising during commissioning, qualification, and facility start-up.

Responsibilities: Represent the business user to ensure that all relevant requirements are met during commissioning and qualification; Manage commissioning and qualification (C&Q) activities for the new manufacturing facility; Lead Performance Qualification (PQ) activities for new manufacturing equipment and assets; Write and prepare Performance Qualification protocols and reports; Troubleshoot technical issues and challenges related to the new facility; Lead root cause investigations into equipment-related issues during commissioning, qualification, and start-up; Collaborate with multidisciplinary teams and coordinate project activities; Support reliable, compliant, and cost-effective pharmaceutical manufacturing processes.

Requirements: Master's degree or PhD in Science, Bioprocess Technology, Pharmaceutical Technology, (Industrial) Chemistry, Food Technology, or a related field; 5–10 years of experience in a technology or manufacturing position; Experience managing Commissioning & Qualification activities and leading Performance Qualification is highly relevant to the role; Experience managing projects and coordinating multidisciplinary teams; Ability to investigate equipment-related issues and identify root causes; Experience with pharmaceutical technology and GMP is an asset; Knowledge of Lean Six Sigma and statistics is an advantage; Excellent communication skills in both English and Dutch are required.

Other information: Apply to our vacancy for more information. Looking forward to getting in touch!