- 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
- Collaborating with global IT and Quality teams
- Following all relevant Environmental, Health, and Safety procedures and assisting in incident investigations as required
- The individual would be responsible for the review/approval of vendor-purchased computer system validation documentation.
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CSV Engineer - Norwood, United States - DPS Group Global
Description
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
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.
Additional
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. Strives to continuously build knowledge and skills.
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. Solicits customer feedback to improve service.
Planning and Organizing Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
Teamwork Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others views. Gives and welcomes feedback. Puts success of team above own interests.
Use of Technology Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
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 and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
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.
