Lead CQV Validation Engineer​/Lead Validation Engineer

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

The CQV Validation Engineer family of roles execute commissioning, qualification and validation projects involving new or modified systems/equipment, processes, procedures, products, facilities, and utilities. In this role, validation engineers support the validation and change life cycles for client’s systems in pharmaceutical and medical device manufacturing, and packaging operations to meet timeline, budget, quality, regulatory compliance, and client expectations.

Lead CQV Validation Engineer Responsibilities

• A recognized leader in the industry and senior individual capable of designing and executing validation projects of any scope, scale, or level of complexity
• Actively consult clients on regulatory validation processes and standard industry acceptable practices
• Support validation audits and large-scale remediation efforts
• Act as subject matter expert in all areas of system compliance and validation
• Managing the responsibilities on multiple simultaneous projects and/or clients
• Driving the activities as client facing leader and responsible party
• Act as the defined point of escalation and issue management on client projects
• Fluent in working with equipment OEMs and installation vendors
• Designing validation plans
• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• Independent verification of testing against specifications
• Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities
• Ability to complete root cause analysis
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed qualification and validation records
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing…