Senior Computer System Validation (CSV) Specialist

Keywords for Sourcing: CSV, Computer System Validation, CSA, Computer Software Assurance, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, GMP, GLP, GCP, IQ, OQ, PQ, URS, FS, Validation Plan, Traceability Matrix, Validation Summary Report, CAPA, Change Control, Data Integrity, Pharmaceutical, Biotech, Medical Device, Quality Systems, SDLC, Compliance. Preferred qualifications include 7-10 years of CSV experience, at least 1 year working under FDA CSA guidance, experience supporting audits, CAPAs, and change controls, ASQ Certifications (CSQE, CQA, CQE), PMP or Agile certification, and experience with laboratory, quality, manufacturing, clinical, or enterprise systems.

Sr. Computer Systems Validation Specialist Opportunity!!

This Jobot Consulting Job is hosted by: Robert Reyes
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $60 - $90 per hour

A bit about us:

Global Laboratories is a recognized leader in global clinical trial testing and central laboratory services. Through wholly-owned facilities and our network of partner labs, we support clinical trials in more than 65 countries around the globe including, the U.S.A., the United Kingdom, India, and Singapore.

Our network affords us flexibility in executing clinical trials and extends beyond Global facilities to include well-established relationships with trusted reference laboratories should your studies require additional support.

Why join us?

Competitive Salary$$
Stellar Benefits (Medical, Dental Vision, Life Insurance)
Flexible Schedule
Job Stability
Career growth
The position offers a competitive salary
If you are passionate, thrive in a fast-paced environment and are ready to take your career to the next level, we would love to hear from you.

Job Details

Job Details:
We are seeking a dynamic and experienced Consulting Senior Computer System Validation (CSV) Specialist to join our team. The ideal candidate will be responsible for the validation of GxP computerized systems to ensure compliance with company policies and regulatory requirements. This is a fantastic opportunity for an individual with a strong background in computer system validation within the biotech, pharmaceutical, medical device, or laboratory environments to leverage their skills and experience in a challenging and rewarding role.

Responsibilities:

• Lead and execute computer system validation projects in compliance with regulatory requirements and company policies.
• Develop and maintain validation documentation, including User Requirement Specifications (URS), Functional Specifications, Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Summary Reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Work closely with cross-functional teams to support audits, CAPAs, and change controls.
• Provide expert guidance on Computer Software Assurance (CSA) and GAMP 5.
• Support the implementation and maintenance of quality systems, ensuring compliance with GMP, GLP, and GCP standards.
• Participate in the software development lifecycle (SDLC) from a compliance perspective.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field.
• Minimum of 5 years of Computer System Validation (CSV) experience in biotech, pharmaceutical, medical device, or laboratory environments.
• Proven experience validating GxP systems.
• Strong working knowledge of Computer Software Assurance (CSA), GAMP 5, 21 CFR Part 11, EU Annex 11, and Data Integrity (ALCOA+).
• Experience authoring validation documentation: URS, Functional Specifications, Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, Validation Summary Reports.
• Preferred qualifications include 7-10 years of CSV experience, at least 1 year working under FDA CSA guidance, experience supporting audits, CAPAs, and change controls, ASQ Certifications (CSQE, CQA, CQE), PMP or Agile certification, and experience with laboratory, quality, manufacturing, clinical, or enterprise systems.
• Excellent written and verbal communication skills, strong analytical skills, and the ability to work effectively in a team environment are essential.

Keywords for Sourcing:
CSV, Computer System Validation, CSA, Computer Software Assurance, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, GMP, GLP, GCP, IQ, OQ, PQ, URS, FS, Validation Plan, Traceability Matrix, Validation Summary Report, CAPA, Change Control, Data Integrity, Pharmaceutical, Biotech, Medical Device, Quality Systems, SDLC, Compliance.

Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.

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