What are the responsibilities and job description for the Biotech Validation Engineer position at Actalent?
Description:
Consult with management, evaluate customer requirements, and studies product characteristics to select validation objectives and standards. • Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems. • Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications. • Maintain technical records within design history files associated with assigned products. • Collaborate and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing. • Identify root causes of production problems. • Identify nonconformities of product or process standard and offers recommendations for resolving deviations. • Develop and maintain databases for tracking test results, validation activities, or validated systems. • Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices. • Modify testing methods, revisit test objectives and standards to resolve testing problems. • Calibrate equipment to ensure accurate measurements. • Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc. • Participate in system-level and subsystem-level root cause investigation from firmware and electrical perspective, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements. • Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities. • Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications. • Perform other related duties as assigned.
Skills:
Validation protocols, test method, technical writing, Medical device, Iq, Oq, Pq, Validation, Validation testing, Iso 13485, Equipment validation, root cause analysis, corrective action plans
Top Skills Details:
Validation protocols,test method
Additional Skills & Qualifications:
• Bachelor’s degree preferred in Engineering • 3 years’ validation engineering experience. • Technical writing experience • Experience with product and/or equipment validation (IQ / OQ / PQ)
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $90,000 - $115,000
