5958 - Quality Lead / Senior 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

Quality Lead / Senior Validation Engineer Responsibilities:

This position will be responsible for supporting the Quality Information Systems Management group, specifically focused on IT Infrastructure and the Clinical Operations areas. This position will be working closely with the operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement used in these areas. This role will review and approve computerized system lifecycle documentation as well as provide Part 11/ Annex 11, and data integrity expertise to key stakeholders.

Job Responsibilities:

• Provide Quality oversight and system proficiency with Enterprise computerized systems- ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Lab Systems, and Manufacturing Systems
• Take Quality ownership - participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include new implementation, enhancements, quarterly releases, periodic reviews
• Participate in system implementations - provide project teams guidance on system lifecycle activities and validation strategies to be followed using a risk-based approach based on GAMP 5
• Review and approve system lifecycle deliverables for computerized systems used in GxP areas
• Review and approve quality events (deviations & CAPAs), etc.
• Participate and drive system assessments - review and approve project deliverables, including plans, test scripts, execution and its outcome, reports, and traceability
• Participate and drive the discussions on issues to resolutions, adhering to quality compliance
• Highlight any identified quality risks and present possible mitigation options to the project team, and keep them informed of the quality management
• Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation

Job Requirements:

• Bachelor’s degree in IT or Computer Science
• 5+ years of proven experience with computerized systems - Enterprise Level and Lab systems in the validation/quality space
• Drug facility experience with Manufacturing/Lab Quality oversight required
• Strong GMP Quality expertise with an understanding of QMS principles
• Familiarity with ITIL/GAMP 5 Validation Lifecycle
• Practical experience generating process documentation and reports
• Excellent communication skills with the ability to translate data into actionable insights
• Strong working knowledge of relevant computerized systems module, structure design
• Proven capabilities in project and user-testing management
• Proven development of innovative and impactful systems solutions
• Highly proficient technical writing capabilities
• Knowledge of Agile validation lifecycle and methodologies

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range$80,465—$128,535 USD

Benefits