Lab Systems IT Specialist

Summary
DPS Group is seeking a Lab Systems IT Specialist for a client in Lexington, MA.

Successful candidates will set up computers using supplied (computer & OS) computer and image. They will confirm/install applicable enterprise applications for corporate standard anti-virus and related tools. Additionally, candidates will follow Computerized Systems Validation (CSV) process and Software Development Life Cycle (SDLC) methodology to build out and qualify the application.

Responsibilities

• Setup computers using supplied (computer & OS) computer and image. Confirm/install applicable enterprise applications for corporate standard anti-virus and related tools.
• Author and revise systems design and configuration specification documents for new and ongoing projects. Also author the validation documents include incorporating holistic data integrity methodologies, backup/restore testing, disaster recovery planning and related activities.
• Periodic review of QC lab systems (Document review, backup & restore verification, audit trail user review account review.
• Assess pre-existing GXP computer systems for compliance gaps and recommended solutions.
• Participate in cross-functional project teams to ensure business needs are met and implemented in compliance with associated predicate rules and government regulations.
• Proactively monitors systems and processes to ensure compliance with standard operating procedures audit compliance and industry best practices.
• Technical approver for project related CSV/AIQ documents in cross-functional teams that include business owners, IT CSV project engineers, IT systems administrators and systems owners and quality assurance on projects including clinical data repositories, master data management systems, laboratory systems and other systems supporting clinical manufacturing or quality processes.
• Act as business administrator for automated systems, software application, including managing accounts change/patch management and any associated maintenance.
• Can easily from lab systems where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a systems will be used.
• Work with infrastructure teams to assure proper backups of lab systems are setup.
• With various IT tools such as Windows NTFS permissions, active-directory, group policies etc. To implement and deploy with data integrity risk management.
• Deploy workstation and install applications on both client and servers as needed for application
• Support ongoing DI related initiatives, remediation plans and other projects.
• Perform and help with periodic activities like user account reviews, audit trail reviews and admin audit trail reviews as system owner.
• Follow Computerized Systems Validation (CSV) process and Software Development Life Cycle (SDLC) methodology to build out and qualify the application.
• As an application SME, work with infrastructure team to reach system architecture and perform installation of application.
• Directly responsible for deployment as well as authoring validation documents such as system design and configuration specifications (SDCS's) and installation qualifications (IQ), Backup configuration and restore protocols, and systems administration procedures.
• Assist with and provide input as SME and system owner for the other documents in validation process, such as user and/or functional requirements, risk assessment, operational qualification related to software functions, etc.
• As incidents come in, work on trouble shooting and resolving issues for end users for site applications.
• Contacting vendors as needed for troubleshooting and resolving issues.
• Creation/modification of user accounts in applications as needed following administration procedures.
• Developing and executing CSV/AIQ deliverables according to regulatory authorities for GxP computerized systems to support commercial and development activities
• Other duties as assigned

Skills and Qualifications

• 3 years experience in Lab Systems IT
• Bachelors degree in related field
• 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.

#LI-NH1
Summary
DPS Group is seeking a Lab Systems IT Specialist for a client in Lexington, MA.

Successful candidates will set up computers using supplied (computer & OS) computer and image. They will confirm/install applicable enterprise applications for corporate standard anti-virus and related tools. Additionally, candidates will follow Computerized Systems Validation (CSV) process and Software Development Life Cycle (SDLC) methodology to build out and qualify the application.

Responsibilities

• Setup computers using supplied (computer & OS) computer and image. Confirm/install applicable enterprise applications for corporate standard anti-virus and related tools.
• Author and revise systems design and configuration specification documents for new and ongoing projects. Also author the validation documents include incorporating holistic data integrity methodologies, backup/restore testing, disaster recovery planning and related activities.
• Periodic review of QC lab systems (Document review, backup & restore verification, audit trail user review account review.
• Assess pre-existing GXP computer systems for compliance gaps and recommended solutions.
• Participate in cross-functional project teams to ensure business needs are met and implemented in compliance with associated predicate rules and government regulations.
• Proactively monitors systems and processes to ensure compliance with standard operating procedures audit compliance and industry best practices.
• Technical approver for project related CSV/AIQ documents in cross-functional teams that include business owners, IT CSV project engineers, IT systems administrators and systems owners and quality assurance on projects including clinical data repositories, master data management systems, laboratory systems and other systems supporting clinical manufacturing or quality processes.
• Act as business administrator for automated systems, software application, including managing accounts change/patch management and any associated maintenance.
• Can easily from lab systems where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a systems will be used.
• Work with infrastructure teams to assure proper backups of lab systems are setup.
• With various IT tools such as Windows NTFS permissions, active-directory, group policies etc. To implement and deploy with data integrity risk management.
• Deploy workstation and install applications on both client and servers as needed for application
• Support ongoing DI related initiatives, remediation plans and other projects.
• Perform and help with periodic activities like user account reviews, audit trail reviews and admin audit trail reviews as system owner.
• Follow Computerized Systems Validation (CSV) process and Software Development Life Cycle (SDLC) methodology to build out and qualify the application.
• As an application SME, work with infrastructure team to reach system architecture and perform installation of application.
• Directly responsible for deployment as well as authoring validation documents such as system design and configuration specifications (SDCS's) and installation qualifications (IQ), Backup configuration and restore protocols, and systems administration procedures.
• Assist with and provide input as SME and system owner for the other documents in validation process, such as user and/or functional requirements, risk assessment, operational qualification related to software functions, etc.
• As incidents come in, work on trouble shooting and resolving issues for end users for site applications.
• Contacting vendors as needed for troubleshooting and resolving issues.
• Creation/modification of user accounts in applications as needed following administration procedures.
• Developing and executing CSV/AIQ deliverables according to regulatory authorities for GxP computerized systems to support commercial and development activities
• Other duties as assigned

Skills and Qualifications

• 3 years experience in Lab Systems IT
• Bachelors degree in related field
• 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.

#LI-NH1