Summary
DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing facility. 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 in IT knowledge, CSV, ValGenesis, PM knowledge, and EQMS.
Key Responsibilities
- Manage the Computer System Validation aspect of IT projects from software installation 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
- Collaborate with global IT and Quality teams
- Follow all relevant Environmental, Health, and Safety procedures and assist in incident investigations as required
- Review/approve vendor-purchased computer system validation documentation
Additionally, the individual would help with the preparation of any CSV protocols where the service was not provided, as well as any “addendums” required. Field execution would be managed by other personnel.
Minimum Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Continuous Learning – Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others.
- Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
- Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs.
- Planning and Organizing – Prioritizes and plans work activities. Uses time efficiently. Plans for additional resources.
- Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit.
- Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date.
- Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Mathematical Ability - Work with mathematical concepts such as probability and statistical inference.
- Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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