Lead CSV Engineer: GMP Computer Systems Validation

Cellipont; Research Forest (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Cellipont in Texas is seeking a Lead CSV Engineer to lead and execute CSV strategies for GMP computerized systems. The role will involve collaborating with various teams to ensure compliance with regulatory standards and to support the timely release of systems.

Ideal candidates will possess extensive knowledge of compliance requirements and have a proven track record in computerized systems validation. This is an exciting opportunity to make a significant impact in Cellipont's mission of transforming client discoveries into patient cures.

Qualifications

• Extensive knowledge of 21 CFR Part 11 and EU Annex 11 compliance.
• Experience in computerized systems validation for GMP environments.
• Ability to develop risk-based validation approaches.

Responsibilities

• Lead CSV strategy for GMP computerized systems.
• Collaborate with cross-functional teams for project support.
• Define and execute testing strategies for implementations and upgrades.

Skills

CSV strategy and execution

Risk assessment

Data integrity

Cross-functional collaboration

Job description

Cellipont in Texas is seeking a Lead CSV Engineer to lead and execute CSV strategies for GMP computerized systems. The role will involve collaborating with various teams to ensure compliance with regulatory standards and to support the timely release of systems.

Ideal candidates will possess extensive knowledge of compliance requirements and have a proven track record in computerized systems validation. This is an exciting opportunity to make a significant impact in Cellipont's mission of transforming client discoveries into patient cures.