CooperSurgical is a leading fertility and women’s 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, we're driven by a unified purpose to enable patients to experience life's 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 women’s 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 www.coopersurgical.com.

The Junior Computer Systems Validation Engineer supports the validation of computer systems used in regulated environments (e.g., pharmaceutical, biotech, or medical device industries). This role ensures systems comply with regulatory requirements such as FDA 21 CFR Part 11, GxP, and company standards. The position involves assisting in the development, execution, and documentation of validation documents under the guidance of senior level engineers.

Knowledge, Skills and Abilities:

Experience in Computer Systems Validation, Software Quality Assurance of Quality 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 Parts 11, 58, 211, 820, and 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 function's 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, you'll 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 www.coopersurgical.com to 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 place. 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 talent.acquisition@coopersurgical.com

Maintains computer system inventory listing 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 validated systems.
Provides test execution training and assists teams with deviation management.
Ensures validation issues are identified, tracked, reported on, and resolved in a timely manner.

Travel:

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

Computer System Validation Engineer

Junior Computer Systems Validation Engineer