Validation Specialist II

Validation Specialist II

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. Responsible for performing multiple validation disciplines including Software Validation (SV), Equipment Qualification (IOQ) and minor Software Programming. Also responsible for maintenance of the validated state of qualified utilities, equipment and software as required. Responsible for Performing Periodic Reviews of equipment and software per program requirements. The Validation Specialist II helps manage the Software Validation Programs for Solesis Sister Companies Charter Medical LLC and Polyzen LLC to ensure compliance with FDA and current industry software requirements.

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. Responsible for managing consultants on large projects with oversight from upper management. Responsible for Qualifying (IOQ) new direct impact production and support equipment and systems. This involves writing, reviewing, approving and executing validation protocols. Responsible for validating all new direct impact software that is utilized within the Secant Group, Charter Medical or Polyzen Quality Management System. This involves writing, reviewing, approving and executing software validation protocols, User Requirement Specifications (URSs) and Risk Assessments (FMEAs) as applicable. Responsible for maintaining 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. Responsible for supporting Sister Company SanaVita Medical LLC as required concerning equipment qualification and software validation. Drafts documentation needed to support company operations and compliance including SOPs, WIs, Specifications, Test Methods, Change Controls, and CAPA/Nonconformance Reporting. Provides support for additional quality systems and functional areas as needed and/or assigned including, but not limited, to Preventive/Unscheduled Maintenance and Calibration, Validation, Training, Research & Development, and Product/Process Development, Manufacturing and Quality Engineering groups. Assist Validation Manager provide oversight of the Charter Medical and Polyzen Software Validation programs and performs software validations as required. Assess new Charter Medical and Polyzen QMS Software for applications for FDA 21CFR Part 11 requirements. Helps maintain Software and Equipment Validation Master Plans for tracking validation activities and validated system periodic reviews or software version upgrades. Stays current with technical and regulatory requirements and applies new knowledge to the position. Performs additional job-related responsibilities as assigned.

Minimum bachelor's degree in science or engineering. BS in a software or computer related degree preferred but not required with adequate software experience. High level of competence interacting with Computers/Software - Using computers and computer systems (including hardware and software) to configure, program, set up functions, enter data, or process information. 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.