Computer Systems Validation Specialist

Upsher-Smith•Maple Grove, MN

19h•$75,789 - $113,684

About The Position

This position is responsible for establishing and maintaining the validated state for software-based computerized systems in use at Bora Pharmaceuticals Inc. according to the Validation Policy for Computerized Systems and in compliance with FDA and other regulatory requirements. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Establish working relationships with business units, IT and QA to provide appropriate support for their computerized systems validation requirements. Participate in the generation of user requirements and facilitate the traceability from user requirement specifications to test scripts. Support execution of test scripts and perform validation reviews. Preparation of validation plans test plans, protocols, test scripts, reports, and other validation documentation, as requested. Process computerized systems change control requests. Assess validation impact for changes requested in software-based computerized systems. Ensure appropriate documentation is maintained to support the status of validated, software-based computerized systems. Perform administrative tasks for laboratory systems, including user account maintenance, record archival, troubleshooting, and periodic review. Develop and maintain procedures for laboratory systems administrative functions. Investigate unexpected events, classify Incidents and document their impact. Ensure procedures and documentation requirements for change control, qualification and incident handling activities are followed according to approved SOP's. Assist in vendor evaluations and audits, as requested. Assist in regulatory audits, as requested. Support revision of existing procedures as business needs change. Maintain internal tracking logs and supporting documentation to ensure completeness and compliance with SOP's. Stay current with changing business needs and validation requirements for the software-based computerized systems. Perform internal audits on tracking logs and supporting documentation to ensure completeness and compliance with SOP's. Perform risk assessments for new systems and upgrades to existing validated systems. Assist with Quality Systems (eQMS, eDMS) activities, as needed. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Requirements

Bachelor’s degree with minimum 4 years’ experience in pharmaceutical or medical device manufacturing validation or computer systems validation.
Associate's degree in a technical discipline (i.e. Math, Computer Science, Business) and 7 years' experience in pharmaceutical or medical device manufacturing validation or computer systems validation
Minimum 2 years pharmaceutical or medical device experience in computerized systems validation.
Understanding of cGMP and Part 11 regulations and documentation requirements.
Knowledge of network infrastructures, both physical and virtualized.
Working knowledge of SDLC principles.
Acclimated with Microsoft Office software applications (e.g. Word, Excel, PowerPoint, Access);
Ability to read drawings (e.g. wiring/cabling, network architecture).

Nice To Haves

Working knowledge of ERP systems (SAP preferred), laboratory systems (e.g., Waters Empower, Dassault Systèmes Biovia eLN, PerkinElmer UV WinLab, Metrohm OMNIS), and Veeva QualityDocs electronic document management systems.
Understanding of computer programming, (PLC/DCS) preferred.

Responsibilities

Establish working relationships with business units, IT and QA to provide appropriate support for their computerized systems validation requirements.
Participate in the generation of user requirements and facilitate the traceability from user requirement specifications to test scripts.
Support execution of test scripts and perform validation reviews.
Preparation of validation plans test plans, protocols, test scripts, reports, and other validation documentation, as requested.
Process computerized systems change control requests.
Assess validation impact for changes requested in software-based computerized systems.
Ensure appropriate documentation is maintained to support the status of validated, software-based computerized systems.
Perform administrative tasks for laboratory systems, including user account maintenance, record archival, troubleshooting, and periodic review.
Develop and maintain procedures for laboratory systems administrative functions.
Investigate unexpected events, classify Incidents and document their impact.
Ensure procedures and documentation requirements for change control, qualification and incident handling activities are followed according to approved SOP's.
Assist in vendor evaluations and audits, as requested.
Assist in regulatory audits, as requested.
Support revision of existing procedures as business needs change.
Maintain internal tracking logs and supporting documentation to ensure completeness and compliance with SOP's.
Stay current with changing business needs and validation requirements for the software-based computerized systems.
Perform internal audits on tracking logs and supporting documentation to ensure completeness and compliance with SOP's.
Perform risk assessments for new systems and upgrades to existing validated systems.
Assist with Quality Systems (eQMS, eDMS) activities, as needed.