CSV Consultant

Responsibilities:

Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company. Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s)) Ensure Good Documentation Practices, working with policy and procedural governances, assessments, plans, reports etc. Develop and execute FAT/SAT test scripts, qualification protocols and reports based on industry best practices and Client’s / Solution Provider’s documentation system. Review, analyze and evaluate system functions and processes to deliver validation deliverables. Develop approach using science- or risk -based approach that meets regulatory expectation. If a Senior member of the team, serve as Lead for CSV service in one or more of the following disciplines: Production/Manufacturing System (e.g., MES, DCS, Historian) Laboratory Instruments/Equipment/Enterprise system (e.g., LIMS, Empower) Engineering/Automation (e.g., BMS) Emerging technologies (e.g., SaaS platforms, Cloud system)

Professional Skills and Experience:

At least Bachelor’s degree in technical discipline such as Engineering, Science or IT. Graduates of related discipline may also apply. Possess 2 or more years of experience performing CSV activities. Experience in engineering / process automation such as DCS, Historian, MES and/or PLC would be viewed favorably Ability to communicate quality and risk-related concept to technical and non-technical audiences Good written and oral communication skills, presentation, and data analytics with center of excellence Demonstrated ability to work as both a team player and independently Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail Foundational understanding of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11 and regulatory requirements. Experience in Software development / troubleshooting e.g., C#, JavaScript, Visual Basic, operating systems, databases (SQL) and reports/labels (Crystal Report) preferred. Experience in providing supports to Manufacturing Automation, Manufacturing-IT and/or implementation, patch/hotfix and/or SDLC management such as change/ issue/ incident/ release etc. Knowledge of ISO9001, GAMP5, ISA88, ISA95, and other relevant pharmaceutical standards / best practices.

Offering:

Consulting roles for pharmaceutical and medical device clients in strategically relevant projects. Work in a professional consultancy environment within a highly motivated team. Opportunity to develop skills and deliver projects in both technical and qualification / validation scope. Opportunity to take on responsibility and to help shape our organization. Excellent career development and growth opportunities in a premier consulting organization. Structured training program and peer mentoring system towards competence and personal growth.

---