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Required Skills:
-Bachelor’s degree in related field required
-multiple years of experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
-Expertise of validation in a FDA Regulated Environment.
-Knowledge and understanding of
-Direct experience leading or supporting a project team responsible for validation
-Direct experience leading or supporting mixing and cleaning validations for formulation vessels and fill lines.
Day-to-Day:
Insight Global is looking for a Validation Engineers of all levels for a client in Middletown, VA. This person will oversee development and execution of project validation master plans and identify approaches based on risk. The Validation Engineer will also manage timelines, metrics, scope, and site reporting requirements, as needed. This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects.
Key Responsibilities:
• Independently manages validation project work, tracks overall project validation master plan progress and provides dashboard updates to senior management
• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards
• Develops validation strategies and approaches consistent with all applicable site guidance documents and writes protocols for validation or performance testing of manufacturing equipment, processes, or systems
• Applies current validation best practices and knowledge of risk-based validation approaches across a wide range of manufacturing sub-assembly and assembly processes.
•Authors and executes qualifications and validations
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
• Identifies root causes of production problems associated with validation
• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations
• Develops and maintains databases for tracking test results, validation activities, or validated systems
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices
• Identifies scale up and cost savings opportunities and directly plans and supports scale up, optimization, and development of new manufacturing processes
Contractor
Business Services
$80k-98k (estimate)
07/26/2024
08/22/2024
insightglobal.com
BALTIMORE, MD
500 - 1,000
2001
TYLER HODGINS
$500M - $1B
Business Services
We arent just a staffing company. Were a company that cares for others. It might sound lofty, but it's the idea that gets us up everyday, determined to make it true. Insight Global is a company that people can anchor to in moments of triumph, struggle, and every time in between. Whoever you are and wherever you come from, you matter to us and we have your back. Together, anything is possible.
The job skills required for Validation Engineer include Computer Systems, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer positions, which can be used as a reference in future career path planning. As a Validation Engineer, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer. You can explore the career advancement for a Validation Engineer below and select your interested title to get hiring information.