CSV Specialist
OcyonBio
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- Location
- Aguadilla, PR
- Posted
- Oct 14
- 7 days ago
Career path
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About the company
OcyonBio
Pharmaceuticals · 11 to 50 employees
What you'll do
- Develop, review, and execute validation plans, protocols, and reports for computer systems in accordance with regulatory requirements such as FDA 21 CFR Part 11 and GxP guidelines.
- Coordinate and collaborate with IT, quality assurance, and business units to ensure validation activities align with project timelines and compliance standards.
- Perform risk assessments and impact analyses to identify potential compliance issues and recommend mitigation strategies.
- Maintain and update validation documentation and ensure traceability throughout the system lifecycle.
- Support audits and inspections by preparing necessary documentation and responding to regulatory inquiries related to computer system validation.
What you need
- Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
- Proven experience in computer system validation within a regulated environment, preferably in pharmaceutical, biotech, or medical device industries.
- Strong understanding of regulatory requirements including FDA 21 CFR Part 11, GAMP 5, and other relevant guidelines.
- Experience with validation documentation such as URS, IQ, OQ, PQ, and risk assessments.
- Excellent written and verbal communication skills to effectively document and present validation activities.
- Education: a bachelor's degree or a postgraduate degree
Key skills
Computer system validationGAMP 5Validation documentationRisk assessmentsValidation toolsSoftware development lifecycleAgile methodologiesCloud-based system validationCybersecurity considerationsASQ Certified Quality AuditorCertified Validation Professional
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About the Role:
As a CSV Specialist within the Professional, Scientific, and Technical Services industry, you will play a critical role in ensuring the integrity, compliance, and quality of computer system validation processes. Your primary focus will be to develop, execute, and maintain validation protocols and documentation that meet regulatory standards and industry best practices. You will collaborate closely with cross-functional teams including quality assurance, IT, and project management to support system implementations and upgrades. The role demands meticulous attention to detail to identify risks and ensure that systems perform as intended in a controlled and compliant environment. Ultimately, your work will help safeguard data integrity and support the organization’s commitment to regulatory compliance and operational excellence.
Minimum Qualifications:
Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
Proven experience in computer system validation within a regulated environment, preferably in pharmaceutical, biotech, or medical device industries.
Strong understanding of regulatory requirements including FDA 21 CFR Part 11, GAMP 5, and other relevant guidelines.
Experience with validation documentation such as URS, IQ, OQ, PQ, and risk assessments.
Excellent written and verbal communication skills to effectively document and present validation activities.
Preferred Qualifications:
Certification in computer system validation or quality assurance (e.g., ASQ Certified Quality Auditor, Certified Validation Professional).
Experience with validation tools and software such as Veeva, MasterControl, or similar.
Knowledge of software development lifecycle (SDLC) and agile methodologies.
Familiarity with cloud-based system validation and cybersecurity considerations.
Advanced degree or specialized training in regulatory compliance or quality management.
Responsibilities:
Develop, review, and execute validation plans, protocols, and reports for computer systems in accordance with regulatory requirements such as FDA 21 CFR Part 11 and GxP guidelines.
Coordinate and collaborate with IT, quality assurance, and business units to ensure validation activities align with project timelines and compliance standards.
Perform risk assessments and impact analyses to identify potential compliance issues and recommend mitigation strategies.
Maintain and update validation documentation and ensure traceability throughout the system lifecycle.
Support audits and inspections by preparing necessary documentation and responding to regulatory inquiries related to computer system validation.
Skills:
The required skills enable the CSV Specialist to meticulously plan and execute validation activities ensuring systems meet stringent regulatory standards. Strong analytical skills are used daily to assess system risks and compliance gaps, while communication skills facilitate collaboration with diverse teams and clear documentation of validation processes. Proficiency in regulatory frameworks guides the development of compliant validation protocols and reports. Preferred skills such as familiarity with validation software and cloud technologies enhance efficiency and adaptability in managing modern systems. Together, these skills ensure the specialist can maintain high-quality standards and support continuous improvement in system validation practices.