Computer System Validation for MES

at  Pharmeng Technology Inc

PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.
Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.
PharmEng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.
PharmEng Technology is seeking full-time experienced CSV Engineer in Limerick, Ireland, dedicated to the implementation of MES/IT solutions.

DESIRED BACKGROUND/EXPERIENCE/ATTRIBUTES:

• Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces
• Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
• Experience of MES (Syncade), IT systems such as Tulip, Kneat, ALM, Service NOW, Quality Docs is an advantage.
• Experience of data analytics and reporting solutions is an advantage
• Experience of server and workstation platforms and working in a Win 10 environment
• 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
• Capable of relating well to other people with whom s/he comes in contact

ROLE SUMMARY

The Computer System Validation Engineer will be responsible for the Computer System Validation of MES/IT solutions being implemented for a continuous manufacturing facility.
We are seeking an enthusiastic and experienced computer system validation engineer to join our team on a long-term contract basis. The Computer System Validation Engineer will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.
The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

ROLE WILL INVOLVE:

• Manage the Computer System Validation aspect of IT projects from software install to business release
• Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
• Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions
• Generate computer system validation documentation in accordance with site procedures and GMP guidelines
• Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
• Work with the business to identify and implement procedural controls to mitigate issues found during testing
• Initiate and implement Change Control activities in accordance with Quality Standards and Practices
• Determine solutions or recommendations for changes and/or improvements
• Prioritize validation activities in line with the project schedule
• Collaborating with global IT and Quality teams Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required