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Equipment Validation Engineer
3 months ago
This pivotal role involves spearheading the creation, development, and support of validation processes, as well as implementing ongoing optimization and harmonization strategies for production-scale manufacturing equipment.
Successful candidates will bring a proven track record in production-scale validation, with specific experience in powder blending or handling active ingredients considered advantageous.
This is a hybrid opportunity.MAIN RESPONSIBILITIES:
Assist to create, develop and provide support for validation and ongoing optimisation and harmonisation strategies for production scale product manufacturing related equipment.
Assist to create process validation and equipment qualification protocols and reports (which may include FAT).Assist with review of qualification/validation protocols including support to global manufacturing sites.
Assist to maintain the status of global master specifications for manufacturing equipment, and the global master manufacturing documentation for excipient blends.
Prepare validation, stability and qualification protocols and subsequent reports.Assist with the evaluation & validation of raw materials from both current and new suppliers.
Provide assistance for trials carried out with suppliers and / or customers.
Formally stability test products containing these raw materials.
EXPERIENCE REQIURED
Essential
Degree (or equivalent) in science or engineering related qualification
Proven experience of Validation of Equipment in a manufacturing environment
Proven validation experience within a highly regulated manufacturing environment (Medical Devices, Pharmaceutical, Food etc.)
Knowledge & experience of excipient blend products and raw materials
Report WritingDesirable
Experience of process development, optimization, scale-up & validation studies
Experience of equipment evaluation & qualification studies
Proven knowledge and experience of Change Control and Risk Management processes.
Knowledge and experience of EXCiPACT and/or ISO 9001 requirements is highly advantageous.
ISO / GMP / GLP /COSHH / H&S awareness
This is a hybrid opportunity with the added benefit of a flexi-time scheme #J-18808-Ljbffr
