Validation Specialist II
HybridTelford, Pennsylvania, United States
Job Summary
Coordinate and implement activities for compliant support of Secant Group Validation functions, including Software Validation, Equipment Qualification, and minor programming. Perform periodic reviews of equipment and software, manage consultants on large projects, and draft documentation for SOPs, test methods, and change controls. Qualify new production equipment and validate new software by writing, reviewing, and executing protocols, URSs, and risk assessments. Maintain the validated state of systems through addendums or verification memos and assist the Validation Manager in overseeing software validation programs for Sister Companies. Support audits and inspections, assess QMS software for FDA 21CFR Part 11 requirements, and stay current with technical and regulatory standards.
Required Qualifications
- Minimum bachelor's degree in science or engineering
- High level of competence interacting with Computers/Software
- 2-5 years' experience with writing Software User Requirements Specifications, performing Risk Assessments and writing/executing Software Validation protocols
- 1-3 years Equipment Qualification (IOQ) experience in a regulated environment
- Knowledge of regulated environment and Quality Management System (QMS) (e.g., FDA GMP Part 820 and/or ISO 13485)
- Knowledge of web-based programs, software and database applications and technologies
- Understanding of FDA 21CFR Part 11 for Software Validation
- General understanding of ISPE GAMP5 Software Validation Guidance
- Ability to write Detailed Design Documents and Functional Requirements Specifications
- Experience working in a cleanroom environment
Desired Qualifications
- BS in a software or computer related degree
- adequate software experience
- Knowledge of regulated environment and Quality Management System (QMS) (e.g., FDA GMP Part 820 and/or ISO 13485)
- Understanding of FDA 21CFR Part 11 for Software Validation
- General understanding of ISPE GAMP5 Software Validation Guidance
- Ability to write Detailed Design Documents and Functional Requirements Specifications
- Experience working in a cleanroom environment
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