Validation Engineer

Qualifications:

• Degree required: Level 8 bachelors related engineering degree: mechanical, manufacturing etc
• Proven experience: 2-5 years minimum experience, automated manufacturing experience an advantage
• Equipment qualification / validation desired

Responsibilities:

Primary responsibilities for the Validation Engineer include the following:

• Contribution in NPI (New Product Introduction) development
• Project validation support including conducting Risk assessments (FMEA), requirements and qualification for new equipment URS/IQ/OQ/PQ and PV
• Authoring project validation master plans; SOP and documentation updates
• Authoring validation protocols and final reports, executing validation studies, analysis of validation data
• Resolving technical issues encountered during study execution.
• Works with moderate work direction and is skilled and knowledgeable to the position.
• Work collaboratively with cross-functional teams including engineering, production, quality assurance, supply chain, and outside suppliers. Maintains excellent rapport with internal/external customers
• Identifies process bottlenecks and devises solutions to resolve
• Provide hands-on support for product and process development
• Provide hands-on support for maintaining and fixing process equipment