Job Description

HELLO,

WE ARE SEEKING A COMPUTER SYSTEM VALIDATION ENGINEER FOR OUR PROJECT.

The Computer system Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

REQUIRED COMPETENCIES-KNOWLEDGE, SKILLS, AND ABILITIES: • Strong working knowledge of MS Windows client and server technologies. • Working knowledge of standard networking principles and technologies • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry • Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance • Ability to work with the end user to identify and document User and Functional Requirements • Knowledge of pharmaceutical laboratory and manufacturing systems. • Experience executing equipment qualification documents • Ability to interact effectively with laboratory, QA, and Facilities groups • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously • Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation • Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification. EDUCATION & EXPERIENCE: • BS degree in Engineering / Computer Science or equivalent • Minimum 1years in CSV • Ability to work safely when working alone, or working with others.

Thanks and Regards,

Suchi

suchi@vastekgroup.com

Company Description

Vastek is a Minority owned company catering to Top Fortune Companies for their Staffing and Contingent Workforce requirements Contingent workforce / Permanent staffing sourcing category Vastek specializes in providing potential candidates with sound knowledge in High Technology, Information Technology, Defense and Aerospace Engineering to support various client projects. We have more than 200 candidates working all over US predominantly in the software development discipline.We are mid sized company and provide IT Services. we supply consultants to top 500 Inc Companies. We are specialized into Security Engineers, Data Base Administrators, Citric Engineer/Analyst, In for/Lawson Analyst, Pharma, Business Analyst, Data Analyst, Business Systems Analyst, Validation Engineer, Test Engineer, Quality Analyst, Quality Engineer, Systems Analyst , Computer Systems Validation and Clinical Business Analyst, QA Tester roles. We are located at 1230 Columbia St, Suite-1180, San Diego, CA-92101.