Sr. Computer Systems Validation Engineer

CooperCompanies • $110K — $130K *
Trumbull, CT 06611In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 7+ years in business processes and support systems for QA and Compliance departments
  • 5+ years specialized in Computer Systems Validation
  • Bachelor's degree in Computer Engineering or relevant science field, or equivalent experience
  • Knowledge of regulatory requirements (e.g., FDA 21 CFR)
  • Ability to engage with cross-functional teams effectively

Responsibilities

  • Lead Computer Systems Validation efforts across enterprise programs
  • Propose and implement efficient approaches for CSV governance
  • Manage and drive validation projects and specific tasks within larger initiatives
  • Enhance inspection readiness and promote continuous improvement within the CSV team
  • Train and mentor staff on computer systems lifecycle methodology
  • Collaborate closely with IT and various departments to guide CSV initiatives
  • Ensure proper documentation and compliance with relevant policies

Benefits

  • Comprehensive health benefits including medical, dental, and vision
  • Flexible work arrangements with opportunities for remote work
  • Professional development and continuous learning opportunities
  • Supportive work culture with a focus on collaboration and teamwork
  • Possible international travel opportunities for project oversight
Full Job Description
Job Description

Scope:

The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (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 risk-based, inspection-ready validation culture across the organization.

Responsibilities

Essential Functions & Accountabilities:
  • Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high-risk 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, projgram management, 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.


Qualifications

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 in support of GxP operations, and Computer System Validation documentation including, the authoring of plans, requirements, risk assessments, test protocols, test reports, traceability matrices, and summary reports.
  • Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent systems.
  • Regulatory requirements including: CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
  • Ability to effectively engage and collaborate with cross-functional teams such as: IT, Regulatory, Quality Assurance, PMO, R&D, project stakeholders, business owners, system owners, etc.
  • Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
  • Strong analytical and problem-solving skills with the 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: QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA, etc.), and Project/Task Management.


Work Environment:
  • Prolonged periods of sitting, especially in front of a computer.
  • Potential exposure to different manufacturing environments and following various safety protocols.


Experience:
  • 7 +years of experience in the assigned function's 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.

About CooperCompanies

CooperCompanies Careers

Joining CooperCompanies presents an unparalleled opportunity to become part of a global team dedicated to fostering innovation, leadership, and professional growth. As a leading entity in the medical sector, CooperCompanies offers a range of job opportunities that cater to a diverse set of skills and experiences.

Explore Career Opportunities

CooperCompanies is actively hiring and continuously seeks passionate, creative, and solution-driven team players. Explore open positions that align with your professional interests and expertise. Each position at CooperCompanies is a chance to thrive in a culture that values diversity and leadership.

Professional Growth and Development

At CooperCompanies, career growth is a priority. The company supports professional development through comprehensive training programs, including leadership development and diversity training. These initiatives ensure that every team member has the tools and knowledge to advance their career.

Innovation and Team Collaboration

Innovation is at the heart of CooperCompanies. The team collaborates on projects that push the boundaries of technology and service in the medical field. Working at CooperCompanies means joining forces with some of the brightest minds in the industry to deliver solutions that truly make a difference.

Internship Programs

For those starting their career journey, CooperCompanies offers internship programs that provide a robust introduction to the medical industry. Internships are a pivotal step for gaining real-world experience, enhancing your resume, and building a professional network.

Benefits and Company Culture

CooperCompanies is committed to supporting its employees with exceptional benefits and a nurturing work environment that promotes a balance of professional and personal growth. The company culture is built on a foundation of respect, inclusion, and collaboration, making it a prime workplace for individuals from all walks of life.

Networking and Industry Leadership

Employees at CooperCompanies are encouraged to engage in networking opportunities within and beyond the company. This connectivity is vital for fostering relationships that can lead to innovative collaborations and career advancement.

Applying for a Position

To apply for a position at CooperCompanies, candidates should prepare their resume to highlight relevant experience and skills. The interview process is designed to assess fit both for the candidate and the company, ensuring alignment with CooperCompanies' core values and business objectives.

Stay Connected with CooperCompanies Careers

Keep up to date with the latest job opportunities, company news, and industry insights by subscribing to the CooperCompanies careers newsletter. Discover the exciting and rewarding career opportunities that await at CooperCompanies.

Search CooperCompanies Jobs

Interested candidates are invited to search current job listings and find positions that match their skills and career aspirations. Join CooperCompanies and be part of a team that is dedicated to making a significant impact in the healthcare industry.
Learn more about CooperCompanies
Industry
Healthcare
* Ladders Estimates

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