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Production Equipment Specialist
Leiden, Netherlands | Fulltime/Parttime | Permanent position
About the role
As a Production Equipment Specialist, you help bring new manufacturing equipment and technologies into our production environment, from balances to automated filling and packaging lines. You connect Production with Engineering, Validation, Quality and external partners to ensure equipment is implemented safely, efficiently and in line with GMP requirements. Your work makes a direct contribution to reliable production operations and continuous improvement.
What will you do?
* Represent Production as the subject matter expert in equipment selection, design, supplier evaluation, FAT/SAT, installation, qualification, start-up and handover.
* Translate operational needs into user requirement specifications and coordinate Production deliverables, implementation plans and project risks.
* Work closely with Engineering, Technical Services, Validation, Automation, Quality and suppliers to ensure successful equipment implementation.
* Prepare Production for new equipment and processes, including documentation, work instructions, training and transfer into routine operations.
* Support equipment qualification, change controls, deviations, CAPAs and risk assessments in accordance with GMP and internal quality requirements.
* Investigate equipment malfunctions and process issues, coordinate troubleshooting and verify that equipment can safely return to operation.
* Monitor equipment performance and contribute to process improvements, upgrades, replacement projects and equipment lifecycle management.
Your profile
* A bachelor’s degree in engineering, a technical or pharmaceutical discipline and at least five years of experience in GMP-regulated pharmaceutical manufacturing.
* Experience with manufacturing and/or packaging equipment implementation projects and a strong understanding of GMP and quality requirements.
* Knowledge of commissioning, qualification, validation or technology transfer; project management experience is an advantage.
* Strong technical and analytical skills, with a proactive, practical and solution-oriented approach to troubleshooting and improvement.
* Clear communication and collaboration skills, a strong sense of ownership and accountability, and the ability to train and coach Production colleagues.
We offer
* Competitive salary, including 13th months and annual reward scheme
* 25 vacation days (based on a fulltime agreement)
* 5 additional vacation days
* NS business card or;
* Travel allowance by car or bike
HAL Allergy, for those who seek pharmaceutical innovation
HAL Allergy develops, manufactures and distributes allergen immunotherapies for the treatment and prevention of allergic diseases. Patient well-being is at the heart of our work. More than 300 specialized colleagues collaborate across disciplines in an international pharmaceutical environment. Our headquarters in Leiden brings development, manufacturing and commercial activities together at Leiden Bio Science Park. We offer an informal, diverse working environment where collaboration, initiative and continued development are encouraged.
Interested? Let’s connect!
Apply directly via Linkedin.
Application process
Our recruitment process typically includes an interview with the hiring manager and second round with important stakeholders. Depending on the position, an additional interview may be part of the process.
Questions?
Contact the HR Department via