Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures, and services.

Job Summary

The CSV Engineer will be responsible for assessing software quality on newly purchased and existing QCL and production Lab Instruments.

We are seeking an enthusiastic and experienced CSV Engineer to join our team on a long-term contract basis. The CSV Engineer will conduct testing to ensure the software purchased from Lab Instrument vendors is fit for purpose and any issues are removed or mitigated before release to QCL Labs and Manufacturing Operations.

The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/interpersonal skills, a keen eye for detail and the ability to work on their own initiative.

Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

Job Responsibilities:

• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines.
• Experience of server and workstation platforms.
• Experience of SQL databases would be an advantage.
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• Self-motivated, detail-oriented, and excellent organizational and time management skills.
• High-level technical writing skills.
• Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area
• Executing test scripts in HP-ALM and reviewing results
• Reporting and documenting technical issues and driving resolutions throughout the testing process
• Ensuring all tests and procedures meet company and industry standards.
• Analyzing test results, detecting issues and tracking root cause
• Reviewing and analyzing System Overview and Design specifications
• Apply critical thinking to identify Data Integrity and compliance risks and develop a control strategy (systems, procedures, training)
• Suggesting fixes and improvements and sharing technical expertise with the team
• Modifying and reviewing existing CSV documentation and following up on gaps or discrepancies
• Developing best practices that will increase efficiency and consistency of the testing process.

The Ideal Candidate

• Minimum 3 years’ proven experience as a Test Engineer or similar role
• Good working knowledge of HP-ALM
• Experience of analyzing and challenging s/w to identify gaps.
• Ability to document and troubleshoot errors.
• Analytical mind and problem-solving aptitude.