Place of work:
Michalovce

Salary:
from 1300EUR/month (The final salary depends on the amount of experience)

Contract type:
full-time

Start date:
ASAP

About the role:

As a Validation Engineer you will be working on projects leading to the introduction of new products and processes.

Act as Validation Subject Master Expert specifically for new equipment introduction; developing validation strategies which ensure efficient and robust introduction of new equipment, ensuring documentation and validation activities meet required standards.

Your key duties and responsibilities as a Validation Engineer:

• The Validation Engineer must participate early on in new product development project, with achieving knowledge and all needed information to develop validation approach
• Draft Master Validation Plans (MVP) for new equipment and/or change control projects
• Determine the most efficient and high quality validation strategies for both pilot and scale up manufacturing equipment, recommend and create validation and qualification approaches, priorities, with required timings & resource requirements
• Liaise with software validation Subject Matter Experts (SMEs) and supplier software design engineering to determine best software validation approaches, and build into master validation plans
• Ensure material availability and line side in readiness for validation runs
• Line side at Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) as well as installation of equipment, with technical leads, engineers as required
• Perform and carry out site based validation activities including where needed, overseeing, and or creation and execution of protocols /reports, establish and maintain the technical documentation throughout the project inline with appropriate standards/procedures
• Recommend early Design of experiments (DOEs), trials on equipment to optimise delivery of validation downstream
• Review the equipment User Requirement Specifications (URS), assess the equipment proposals/designs to ensure a robust validation approach can be achieved
• Train other engineers to meet expected standards in protocol writing and reporting, as required
• Act as consult/reviewer and approver where needed for external manufactured new product equipment; validation plans and protocols
• Ensures knowledge and expertise around the product and key equipment processes are handed over to local site engineering/manufacturing

About you:

• At least 2-5 years of relevant work experience as process, quality or validation engineer
• Knowledge and experience in operations, manufacturing, or engineering is essential
• Working with cross functional teams across R&D and Manufacturing

Preferred:

• Experience in equipment and process validation and capability studies
• Experience with manufacturing quality – process FMEA, quality control

Education / Qualifications:

• Education at university level in engineering or scientific
• Project Management knowledge
• Must be proficient with PC programs  i.e. Office (Excel, Word, and PowerPoint, Outlook/Teams)
• Statistical tools like Minitab, Project Management (Microsoft Project, etc.) – preferred
• Communicative level of English language

Contact:

astell@astell.sk