NL CW Engineer Breda • SIRE Life Sciences

The Company
Our client is a pioneering organization dedicated to advancing science and technology to improve lives. With a strong focus on innovation, we leverage cutting-edge research to develop treatments for serious diseases, continuously expanding their pipeline to address unmet medical needs.

Role Description
The CQV Engineer will support technical projects under minimal supervision and report to the Sr. Manager Validation & Compliance within the site Engineering organization. This role requires hands-on commissioning and qualification skills. The CQV Engineer will be responsible for developing, implementing, and reporting test strategies for technical solutions in alignment with internal customer requirements and standard CQV procedures. The Engineer will drive the development of system commissioning, qualification, and validation documentation.

Responsibilities
Documentation
-Develop and update various validation documents, such as:
System Level Criticality Assessments
-Validation, Commissioning, Qualification plans
-Risk assessments
-Test Protocols
-Requirement traceability matrixes
-Commissioning, Qualification, and Validation summary reports
Testing
-Lead commissioning, qualification, and validation activities.
Technical Support 
-Deliver guidance to the project group to ensure that the technical solution aligns with the validation plan, meeting internal customer requirements, and is in accordance with SOPs.
Other Tasks/Projects 
-Execute any other tasks or projects assigned by the supervisor.

Qualifications
-At least 3 years of experience in executing Commissioning, Qualification, and --Validation (CQV) within pharmaceutical manufacturing organizations.
-Experience with secondary packaging systems, including Print and Inspection systems (e.g., Systech, Cognex).
-Hands-on commissioning and qualification experience within Secondary Packaging Operations.
-Experience in Computerized Systems Validation.
Skills & Knowledge 
-Strong understanding of the role of a single document within the broader project scope.
-Ability to work within internal and external reporting relationships.

Requirements
-Ability to work independently and remotely with minimal direct supervision.
-Proficient in English Technical Writing.
-Excellent communication skills.
-Strong customer relationship management skills.
-Critical thinking and problem-solving skills.
-Ability to set clear priorities and escalate issues to ensure timely project delivery, including design, development, implementation, testing, construction, commissioning, and validation.
-Experience working in a GMP-compliant environment, understanding practices, policies, procedures, legal requirements, and project goals.
-Ability to develop supporting documentation and monitor project scheduling and activity timelines.
-Capable of anticipating, evaluating, and resolving multiple simultaneous project issues, delays, and problems by utilizing technical and business expertise.

Other Information
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Stefan Charles via what’s app:

54976