Insight Global is seeking a Computer System Validation (CSV) Specialist role iat a global high tech manufacturing company. The Specialist manages the
validation deliverables for computer systems to support product quality and compliance with internal/external
standards, procedures, and regulations. The role requires applying specialized validation and regulatory knowledge
mainly in the Medical Devices manufacturing area. The roles responsibilities require a high level of independence,
proactiveness, ownership, accountability, and communication (written/verbal) with diverse and global stakeholders
and teams. The role also requires deep analysis, critical thinking, judgment calls, prioritization, continuous learning,
and supporting/training others.
Responsibilities
Develops and executes validation and testing plans, deliverables, and procedures that are consistent with
the Celestica standards and the industry validation frameworks and principles (ex: GAMP 5, FDA CSA).
Applies regulatory requirements and standards to systems, processes, and projects (ex: FDA Parts 11/820,
EU GMP/MDR, ISO 9001/13485).
Supports validation projects that use Software Development Life Cycle (SDLC) methodologies (ex:
waterfall, agile). Creates, executes, and reviews validation deliverables within an SDLC process.
Independently manages the CSV workstream deliverables of a project or change requests. Seeks support
from management, other team members, or Subject Matter Experts (SMEs) as needed. Supports others in
understanding and applying validation procedures.
Analyzes a systems intended use, business/technical processes, data flows, requirements, design,
suppliers, and/or operations to identify GxP impacts and risks for projects and change requests.
Recommends mitigations and approaches to handle GxP risks and impacts.
Creates risk-based validation plans and reports for diverse business/technical systems, projects, and
change requests. Creates and scales the rigor of validation deliverables based on the risk assessments.
Analyzes and suggests improvements to operational change controls and configuration management
procedures for GxP systems.
Creates, maintains, and updates documents/records in accordance with regulatory standards and company
procedures. Recommends records management approaches and improvements for GxP systems and
projects.
Supports the administration of the CSV documentation and records system with minimal supervision.
Reviews validation deliverables created by others for suitability, accuracy, and completeness.
Supports the CSV deliverables of periodic reviews and internal/external audits collaborating with
cross-functional teams. Identifies and reports any deviations or non-conformance findings.
Develops, reviews and/or revises policies, procedures, and guidelines for the CSV Program. Identifies gaps
and improvement areas in the CSV Program and proposes solutions to address them.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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Strong system analysis and system testing planning and execution skills.
Strong understanding of the main industry validation frameworks, ex: GAMP 5, FDA CSA.
Knowledge of the regulatory requirements and standards, ex: FDA Parts 11/820, EU GMP/MDR, ISO
9001/13485
Knowledge and familiarity with the following type of the systems is preferred, but not mandatory:
Manufacturing Execution Systems (MES, ex: Siemens, Plex), Quality Management Systems (QMS, ex:
EtQ), Enterprise Resource Planning (ERP, ex: SAP), Product Lifecycle Management Systems (PLM, ex:
Enovia).
Ability to continuously learn new technologies and business processes and operations willingly and
proactively.
Ability to work and think critically, independently, and proactively with minimal supervision.
Ability to take end-to-end accountability and responsibility to drive assignments and projects to completion.
Strong communication (written and verbal) skills in English.
Ability to build relationships and communicate effectively with diverse and global business/technical
stakeholders and teams.
Strong project and team management and collaboration skills.
Physical Demands:
Duties of this position are performed in a normal office environment.
Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or
on numbers and other detailed data. Repetitive manual movements (e.g., data entry, using a computer
mouse, using a calculator, etc.) are frequently required.
Travel is on need basis only, and is expected to be around 10-15% of the time.
Typical Experience:
5+ years of CSV, QA/Business/System/IT Analysis of experience.
Preferred, but not mandatory, experience in the Medical Device manufacturing industry, other HealthTech
regulated industries such as Pharmaceuticals, and/or the electronics manufacturing industry.
Typical Education:
Bachelor degree in computer science, engineering (computer, industrial, mechanical, electrical),
business/information system management, or equivalent.
Training in validation methodologies, technologies, and process control computer systems.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.