Senior Computer Systems Validation Engineer

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: Trumbull CT (on-site)

Scope:

The Senior Computer Systems Validation Engineeris responsible for validation of global computer systems monitoring changes with regulations and assists team members for CSIs corporate CSV strategy to meet all applicable regulations.

Job Summary:

The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation maintenance and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework overseeing critical programs and complex enterprise systems ensuring regulatory inspection readiness and driving a riskbased inspectionready validation culture across the organization.

• Lead and guide Computer Systems Validation tasks and deliverables through enterprise and highrisk programs throughout the systems life cycle.

• Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.

• Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).

• Drive inspection readiness and continuous improvement in CSV team.

• Train and mentor project team personnel (testers business systems analysts) in computer systems lifecycle methodology.

• Work closely with IT manufacturing quality control quality assurance infrastructure and other teams to provide guidance on CSV.

• Provide guidance with functional/end user requirements compliance and system specifications and ensure proper documentation is maintained to drive operational excellence.

• Provide test execution training and assist teams with discrepancy management.

• Support process owners for quality management systems and associated policies procedures and work instructions.

• Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.

• Ensure compliance with internal and external computer system lifecycle policies and regulations.

• Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.

• Ensure issues are identified tracked reported and resolved in a timely manner.

• Perform other duties as assigned.

Travel: This position may require 5-10% domestic and/or foreign travel.

Knowledge Skills and Abilities:

• Experience in Computer Systems Validation Software Quality Assurance and Quality Management Systems.

• Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.

• Familiarity with computer systems used in support of GxP operations and Computer System Validation documentation including CSV plans requirements risk assessments test protocols (scripts) data migration plans/reports traceability matrices and summary reports.

• Experience and knowledge of various QMSs Agile PLM MasterControl Veeva TrackWise or equivalent system.

• Knowledge of regulatory requirements including CSV CSA FDA 21 CFR Partsand 1271; GAMP ISO 13485 and ISO 14971.
• Ability to effectively engage and collaborate with cross-functional teams including IT Quality Assurance Validation and business project stakeholders.

• Knowledge of business enterprise functions and processes. Experienced in organizing meetings.

• Strong analytical and problem-solving skills with ability to identify issues evaluate options and implement effective solutions.

• Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.

• Skilled in developing following and maintaining procedures and supporting documentation to ensure compliance and consistency.

• Strong written verbal and interpersonal communication skills (ability to communicate effectively with all stakeholders).

• Effective time management skills with proven adaptability to shifting priorities resource changes and scheduling adjustments.

• Ability to work independently and within teams (collaborative environment); self-motivated self-directed and detail oriented.

• Proficiency with Microsoft Office Microsoft D365 and Adobe Acrobat.

• Experience/knowledge of Agile PLM MasterControl IQVIA or equivalent QMS system.

• Experience/knowledge of Waterfall Agile or Hybrid software development.

• Experience/knowledge of automated systems for following activities/functions is preferred:

• Enterprise Resource Planning (Oracle E Business Suite)
• Document management (SharePoint)
• Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)
• Change/Incident Management (ServiceNow)
• Project/Task Management (Smartsheet/Excel spreadsheets)

Work Environment:

• Prolonged periods of sitting especially in front of a computer.
• Potential exposure to different manufacturing environments necessitating adherence to varying safety protocols.

Experience:

• 7 years of experience in assigned functions business process engineering and supporting systems for QA and Compliance departments.

• 5 years of experience in Computer Systems Validation.

Education:

• Bachelor of Science Degree Computer Engineering or relevant science field required or equivalent combination of education and experience.

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Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.