Validation Specialist

About the role

The Validation Specialist II coordinates and implements various activities for compliant and effective support of the Secant Group Validation functions conforming to ISO 13485, internal, and customer requirements. Responsibilities include performing multiple validation disciplines such as Software Validation (SV), Equipment Qualification (IOQ), and minor Software Programming. Additionally, this role involves maintaining the validated state of qualified utilities, equipment, and software as required, and conducting periodic reviews of equipment and software per program requirements.

Responsibilities

• Support Secant Group Customer and ISO 13485 audits and help defend the Software Validation Program during audits.
• Support Charter Medical and Polyzen Customer Audits, ISO 13485 Audits, and FDA Inspections to help defend the Software Validation Program.
• Manage consultants on large projects with oversight from upper management.
• Qualify (IOQ) new direct impact production and support equipment and systems, which involves writing, reviewing, approving, and executing validation protocols.
• Validate all new direct impact software utilized within the Secant Group, Charter Medical, or Polyzen Quality Management System, involving writing, reviewing, approving, and executing software validation protocols, User Requirement Specifications (URSs), and Risk Assessments (FMEAs) as applicable.
• Maintain the validated state of qualified systems (software, utilities, facility, equipment) as required to support any system changes or negative data trending issues by completing IOQ and/or PQ protocol addendums or verification memos as required by the change control systems.
• Provide Software Programming support to IT and Quality Groups of the Solesis Companies as required to maintain production requirements.
• Support Sister Company SanaVita Medical LLC as required concerning equipment qualification and software validation.
• Draft documentation needed to support company operations and compliance, including SOPs, WIs, Specifications, Test Methods, Change Controls, and CAPA/Nonconformance Reporting.
• Support additional quality systems and functional areas as needed and/or assigned, including Preventive/Unscheduled Maintenance, Calibration, Validation, Training, Research & Development, Manufacturing, and Quality Engineering groups.
• Assist Validation Manager in providing oversight of the Charter Medical and Polyzen Software Validation programs and perform software validations as required.
• Assess new Charter Medical and Polyzen QMS Software for applications for FDA 21CFR Part 11 requirements.
• Maintain Software and Equipment Validation Master Plans for tracking validation activities and validated system periodic reviews or software version upgrades.
• Stay current with technical and regulatory requirements and apply new knowledge to the position.
• Perform additional job-related responsibilities as assigned.

Requirements

• Minimum bachelor’s degree in science or engineering. BS in a software or computer related degree preferred but not required with adequate software experience.
• 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 preferred but not required.
• Knowledge of regulated environment and Quality Management System (QMS) (e.g., FDA GMP Part 820 and/or ISO 13485) preferred.
• Knowledge of web-based programs, software, and database applications and technologies required.
• Understanding of FDA 21CFR Part 11 for Software Validation preferred.
• General understanding of ISPE GAMP5 Software Validation Guidance preferred.
• Ability to write Detailed Design Documents and Functional Requirements Specifications preferred.
• Experience working in a cleanroom environment is preferred.