Junior Computer Systems Validation Engineer

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.

• Maintains computer system inventorylisting of all computer systems inventory. Review release notes and perform periodic reviews of validated systems.

• Assist in developing and executing validation protocols (IQ/OQ/PQ) for computer systems and related software.

• Support Risk Assessments for system changes.

• Collaborate with cross-functional teams (Quality Assurance IT and Manufacturing) to troubleshoot and resolve validation issues.

• Maintain validation documentation in accordance with company SOPs and regulatory guidelines. Validation documentation includes validation plans user and system requirements risk assessments test protocols (scripts) data migration plans/reports traceability matrices and summary reports.

• Routes documents for review and approval.

• Maintains validation templates.

• Ability to work on project teams for Software Development Life Cycle phases.

• Performs periodic reviews and supports remediation activities on validatedsystems.

• Provides test execution training and assists teams with deviation management.

• Ensures validation issues are identified tracked reported on 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 ofQuality Management Systems.

• Familiar with Systems Development Lifecycle Management (SDLC) and Change Management methodologies.

• Familiar with computer systems used in support of GxP operations.

• Knowledge of regulatory requirements including FDA 21 CFR Partsand 1271; SOX GAMP ISO 13485 and ISO 14971 with a basic understanding of GxP processes risk-based approaches and validation principles.

• Ability to effectively engage and collaborate with cross-functional teams including IT Quality Assurance Validation and business project stakeholders.

• Knowledge of the business enterprise functions and processes.

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

• Ability to effectively engage 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 abilities.

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

• Demonstrates the ability to work independently and within teams; self-motivated self-directed and detail oriented. Experience working in a team-oriented collaborative environment.

• Ability to communicate effectively with management and in team environments.

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:

• 2 years of experience in assigned functions business process and supporting systems

• 2 years of experience in a QA or IT Compliance department

• Proficiency with Microsoft Office Microsoft D365 and Adobe Acrobat

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

• Experience with Waterfall Agile or Hybrid software development

• Experience with automated systems for following activities/functions is beneficial:

• 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)

Education:

• Bachelor of Science Degree Computer Engineering or relevant science field required

• 2 years in the Computer Systems Validation field

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 at 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. If you are interested in applying and require special assistance or accommodations due to a disability please contact us at