CSV Engineer

Summary

ADPS is looking for a CSV Engineer in Durham, NC to support a client. The client site is upgrading the DeltaV software, as well as replacing the hosting hardware.

As a part of the onboarding the new hardware and software, computer system validation work will be required to meet site Validation requirements.

This will include but not be limited to : Host hardware (HCI), virtual machine configuration, DeltaV software installation (V15.

LTS), data migration from old hardware / software, and verification of connected systems (OSI Pi, Acronis Backup and Recovery, LogMate AMS, etc.).

Responsibilities

• Provide support for Commissioning and Qualification activities for the required system.
• Author and execute Commissioning and Qualification documents, including, but no limited to :
• Qualification Plans
• Development Protocols
• Specifications (Configuration, Software, Design, Functional)
• Risk Assessments
• Qualification Protocol(s) including deviation support during physical execution
• Qualification Reports
• Ensure design specifications are in alignment with qualification strategy and procedures.
• Collaborate and work directly with the team members to complete project deliverables. Ensure to stay informed on general project information including but not limited to decisions, changes, plans of work, due dates, and issues.
• Attend project meetings related to implementation, document reviews, and schedule reviews.
• Track deliverables and milestones and escalate delays to Validation Management.
• Escalate project or technical changes, issues, risks, and outstanding decisions to Validation Management.
• Other duties as assigned

Skills And Qualifications

• Bachelor's Degree in engineering or related field
• Validation related experience
• Knowledge of writing and reviewing validation documentation
• Good understanding of IQ, OQ, PQ, RTM, Test Scripts, Summary Reports, etc
• Strong Attention to Detail
• Self-motivated and reliable
• Knowledge of PC computer operating systems and the Microsoft Office suite
• Strong written and oral communication skills
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

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.

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.