What are the responsibilities and job description for the CSV Engineer position at DPS Group Global?
Summary
DPS Group is seeking a Computer System Validation (CSV) Engineer that will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
Responsibilities
Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
Other duties as assigned
Skills And Qualifications
Bachelor’s Degree with 2 years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments
Knowledge of DeltaV automation platform.
Working knowledge of engineering principles.
Working knowledge and expertise in computerized systems validation.
Computer System Validation experience with DCS, SCADA and BMS systems
Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
Excellent written and oral communication skills.
Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
Ability to work with minimal supervision.
Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
Performs other duties as assigned by management.
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.
DPS Group is seeking a Computer System Validation (CSV) Engineer that will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
Responsibilities
Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
Other duties as assigned
Skills And Qualifications
Bachelor’s Degree with 2 years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments
Knowledge of DeltaV automation platform.
Working knowledge of engineering principles.
Working knowledge and expertise in computerized systems validation.
Computer System Validation experience with DCS, SCADA and BMS systems
Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
Excellent written and oral communication skills.
Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
Ability to work with minimal supervision.
Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
Performs other duties as assigned by management.
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.
