Computer System Validation Engineer

Job description

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving350 clients in more than 23 countries worldwide.

We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry.

We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression.We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Recognize, exemplify and adhere to companys values which centres around our commitment to People, Clients and Performance.

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Must be able to plan and lead validation and qualification activities for multiple complex projects ofany size, which may be regional or global in scope and are occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by and the FDA.

Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors.

These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.

Must be able to conduct meetings for a Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment.

Must be able to create a User Requirements Specification, and assist in the creation of a Functional Requirements Specification and the Technical Design Specification.

Must be able to create all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below.

Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).

Must be completely proficient in all Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer III or below.

Must be able to create, review, and update SOPs and WPs associate with SDLC.

Must be able to conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time.

Must be able to create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to personnel.

Must be capable of representing Validation Services during sponsor audits and conducting external vendor audits.

Focus on meeting project schedules; conducting SDLC, Validation, or Installation Qualification training; and collects metrics.

Keep supervisor and project managers informed of any validation or qualification issues Additional duties as deemed appropriate by the department head/designer.

Requirements Job Requirement: Minimum 5 years of experience in software testing/validation in a regulated environment.

Ability to successfully manage multiple tasks and timelines Ability to effectively liaise with project team members and other teams/departments, on-site and remotely.

Ability to perform and coordinate activities required to bring/maintain systems to a validated state.

In depth knowledge of Software Development Life Cycle and its major phases Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability matrix, Validation Summary Report is required Proven experience in different types of testing (including but not limited to Black Box Testing, Graphical User Interface (GUI) Testing, System Testing (OQ), User Acceptance Testing (PQ), Functional Testing, Regression Testing, etc.) Proven experience in testing applications developed in different programming languages and tools (i.

e.

Java, .Net, Oracle, MySQL, C++) is preferred.

Proven experience with automated testing, preferably the Katelon tool, required.

Strong knowledge of regulatory guidelines on computerized systems, 21 CFR Part 11, Annex 11, and/or GAMP 5.

Understanding of SQL and database concepts is preferred.

Experience in Test Automation Tools or Application Lifecycle Management is preferred.

Strong organizational and problem solving skills for tasks and functions related to testing and validation of applications.

Strong verbal and written communication skills #LI-SK1

4-5 years
Job Requirements: If you are a resilient individual who is proactively looking out for the next big move in your career, here’s what it takes; Bachelor’s degree, or local equivalent, in computer science, mathematics, information systems, information technology or a related field.

EU/APAC: In depth proven experience in computer system validation, preferably in clinical systems.

US/LATAM/CAN: A minimum of 5- 7 years’ experience in computer system validation, preferably in clinical systems.

Must have a solid background in hardware and software required to produce a network topology diagram and to ensure that all installation steps are present in an IQ Protocol.

Considerable knowledge of software development life cycles.

Must be experienced in serving as technical liaison between end users and testers.

Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation.

Required Skill Profession

Other General