Validation Engineer needs 3 to 5 years experience.
Validation Engineer requires:
- Ø BA/BS Required, preferred to be in relevant technical discipline.
- Ø Experience in a cGMP/FDA licensed facility preferred.
- Ø Experience in one or more of the following areas preferred:
- Ø Computer/Software/Systems
- Ø Biomedical Engineering/Mechanical Engineering/Automation
- Ø Medical Technology/Biology/Chemistry or associated science
- Ø Experience in Medical Device, Pharmaceuticals, Life Sciences or Laboratory systems processes / projects
- Ø Must be Quality-minded, detail-oriented and possess excellent writing skills.
- Ø 3 to 5 years experience.
Validation Engineer duties:
- Ø Authors, reviews and/or approves validation documentation including protocols, reports and other sources of information to ensure that validations and procedures are consistent with current industry standards and Regulatory requirements.
- Ø Authors, executes, and reviews of Validation plans, IOQ and PQ protocols, final reports to support manufacturing operations and equipment, laboratory equipment, and production processes within a strictly regulated facility.
- Ø Temperature mapping and other activities to support the facility's continuous process verification program.
- Ø Support changes required for continuous improvement initiatives and change management throughout plant operations.
- Ø Ensures that validation and qualification activities are consistent with company validation policies and procedures.
- Ø Demonstrates a basic understanding of the Product Engineering and Quality Management System concepts.
- Ø Proceeds according to the company's quality policy in all business activities with providers and customers within and outside the company.
- Ø Exhibits a basic understanding of statistical process controls (SPC),the DMAIC process and other quality and manufacturing investigative tools.
- Ø Experience in working with cross-functional teams, including technical and non-technical work.
- Ø Ability to organize and present technical information with minimal assistance.
- Ø Provides training and guidance on aspects of validations and qualifications.