Cure Talent is excited to be partnered with a leading contract manufacturing and packaging company for the Pharmaceutical & Medical Device sectors. Due to their continued growth and development, they are looking for a Process Engineer to support their Operational teams.
As a part of the Process Improvement Team, you will provide hands-on technical support to ensure the successful completion of qualification and validation activities in line with regulatory requirements. You will work on delivering process improvement projects, equipment qualification, and new product introductions, all while driving efficiency and operational excellence. A key focus will be the commissioning of new equipment and the validation of systems and processes for a new manufacturing unit.
In this role, you’ll be involved in improving machinery and equipment processes while contributing to both existing and future manufacturing operations. You’ll work in a dynamic, fast-paced environment supporting small-scale clinical trial production, where adaptability and initiative are essential for success.
Role Responsibilities:
* Lead the commissioning of new equipment and systems for a sterile manufacturing unit, ensuring successful qualification and validation
* Support ongoing manufacturing operations through process improvements for machinery and equipment
* Manage qualification and validation activities, including installation, operational, and performance qualification
* Provide technical support for the introduction of new products and processes into manufacturing
* Engage with regulatory inspections and ensure all documentation and processes meet required standards
To be successful as their new Process Engineer, you will be an experienced Process/Quality/Project Engineer with proven experience in supporting manufacturing and packaging within the pharmaceutical and/or medical device industries. You will have hands-on experience with qualification and validation processes, a strong working knowledge of EU GMP and an ability to work proactively within a small, close-knit team. Strong organisational skills and the ability to manage fast-paced, varied projects will be key to succeeding in this role.
Qualifications & Experience:
* Proven experience in a Process/Quality/Project Engineering role within manufacturing and/or packaging
* Proven experience in the Pharmaceutical or Medical Device industry
* Strong experience with IQ, OQ, PQ processes
* Strong knowledge and experience of GMP
* Practical experience with QMS, deviation investigation management, CAPA planning
If you are a driven and innovative professional ready to make a significant impact in a growing company, we would love to hear from you. Get in touch with Kris Holmes at Cure Talent today