Cypress HCM · 11 hours ago
Validation Engineer
Kenosha, WI
Contract
Onsite
Mid Level
3+ years expCypress HCM is seeking a contract Validation Engineer to join a growing medical device client in Southeastern Wisconsin. The role involves writing, implementing, and analyzing process validation activities while collaborating with Quality Assurance, Manufacturing, and Engineering teams to enhance manufacturing processes.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Provide technical input to validation activities
Represent process validation during equipment installations
Support process validation Quality Systems
Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
Participate in regulatory agency inspections for Process Validation
Serve as one of the main points of contact in communication to customers whose equipment and processes are being validated
Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities
Qualification
Required
3 or more years relevant experience in quality/validation
Experience authoring and completing validation studies
Understanding of cGMP requirements for validation documentation
Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
Experience authoring and building process validation studies for commercial GMP manufacturing processes
Experience troubleshooting/problem-solving and risk assessment/mitigation
Working knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase