Validation Engineer

Gencellprojects; United Kingdom; On-site; GBP 80,000 - GBP 100,000; Full time

Job description

Validation Engineer

40 hours per week

We are looking for a Validation Engineer to join an animal vaccines facility in Surrey. The role is 6 months.

The Validation Engineer should have adequate knowledge of working on FAT & SATs on laboratory equipment which includes chromatography SKIDS, Thermal Mapping & filters.

Job Responsibilities

• This is a pharmaceutical facility where we are looking to identify a Validation Engineer with good equipment.
• Validation requirements for new/improved machines/processes, including system requirements/ design specification, risk analysis; installation qualification.
• Supports the manufacturing plant through implementation of process improvements.
• Manage small projects (both new and improvement) to include cost, implementation, and validation.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.