CSV Specialist

  • location: Durham, NC
  • type: Contract
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job description

CSV Specialist

job summary:
We are seeking a CSV Specialist for a 1 year contract with a BioPharma company in RTP, NC. This is a long-term on-going role and is likely to convert to an FTE after the first year. This resource will be helping with an Empower project, so we are looking for someone with experience performing computer systems validation on Empower.

In addition to CVS work, this resource will also write the user requirements documents, so we need candidates with previous experience doing this.

Primary responsibilities will include:

writing USR documents

documenting configuration of system

writing SOPs for users

writing and executing validation documents

Job Summary:

  • Scope includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Support troubleshooting and process improvement activities.
Job Description:

  • Learn laboratory and manufacturing systems and enterprise-level applications
  • Utilize business and process analysis skills to develop program and process solutions for end users.
  • Complete the execution and documentation of the CSV Program.This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure and support the timely delivery of validated computer systems for internal clients.
Job Requirements:

  • BS, in an Information Technology discipline, Biology / Chemistry, or Engineering field.
  • 5+ years in validation role including experience with Empower
  • experience writing user requirements documents
  • Technical writing ability and good oral communication skills are required.
  • Knowledge of IT concepts, including system administration, network and directory management preferred.
 
location: Durham, North Carolina
job type: Contract
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
We are seeking a CSV Specialist for a 1 year contract with a BioPharma company in RTP, NC. This is a long-term on-going role and is likely to convert to an FTE after the first year. This resource will be helping with an Empower project, so we are looking for someone with experience performing computer systems validation on Empower.

In addition to CVS work, this resource will also write the user requirements documents, so we need candidates with previous experience doing this.

Primary responsibilities will include:

writing USR documents

documenting configuration of system

writing SOPs for users

writing and executing validation documents

Job Summary:

  • Scope includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Support troubleshooting and process improvement activities.
Job Description:

  • Learn laboratory and manufacturing systems and enterprise-level applications
  • Utilize business and process analysis skills to develop program and process solutions for end users.
  • Complete the execution and documentation of the CSV Program.This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure and support the timely delivery of validated computer systems for internal clients.
Job Requirements:

  • BS, in an Information Technology discipline, Biology / Chemistry, or Engineering field.
  • 5+ years in validation role including experience with Empower
  • experience writing user requirements documents
  • Technical writing ability and good oral communication skills are required.
  • Knowledge of IT concepts, including system administration, network and directory management preferred.
 
qualifications:
We are seeking a CSV Specialist for a 1 year contract with a BioPharma company in RTP, NC. This is a long-term on-going role and is likely to convert to an FTE after the first year. This resource will be helping with an Empower project, so we are looking for someone with experience performing computer systems validation on Empower.

In addition to CVS work, this resource will also write the user requirements documents, so we need candidates with previous experience doing this.

Primary responsibilities will include:

writing USR documents

documenting configuration of system

writing SOPs for users

writing and executing validation documents

Job Summary:

  • Scope includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Support troubleshooting and process improvement activities.
Job Description:

  • Learn laboratory and manufacturing systems and enterprise-level applications
  • Utilize business and process analysis skills to develop program and process solutions for end users.
  • Complete the execution and documentation of the CSV Program.This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure and support the timely delivery of validated computer systems for internal clients.
Job Requirements:

  • BS, in an Information Technology discipline, Biology / Chemistry, or Engineering field.
  • 5+ years in validation role including experience with Empower
  • experience writing user requirements documents
  • Technical writing ability and good oral communication skills are required.
  • Knowledge of IT concepts, including system administration, network and directory management preferred.
 
skills: We are seeking a CSV Specialist for a 1 year contract with a BioPharma company in RTP, NC. This is a long-term on-going role and is likely to convert to an FTE after the first year. This resource will be helping with an Empower project, so we are looking for someone with experience performing computer systems validation on Empower.

In addition to CVS work, this resource will also write the user requirements documents, so we need candidates with previous experience doing this.

Primary responsibilities will include:

writing USR documents

documenting configuration of system

writing SOPs for users

writing and executing validation documents

Job Summary:

  • Scope includes supporting all aspects of the Computer Systems Validation (CSV) Lifecycle.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Support troubleshooting and process improvement activities.
Job Description:

  • Learn laboratory and manufacturing systems and enterprise-level applications
  • Utilize business and process analysis skills to develop program and process solutions for end users.
  • Complete the execution and documentation of the CSV Program.This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure and support the timely delivery of validated computer systems for internal clients.
Job Requirements:

  • BS, in an Information Technology discipline, Biology / Chemistry, or Engineering field.
  • 5+ years in validation role including experience with Empower
  • experience writing user requirements documents
  • Technical writing ability and good oral communication skills are required.
  • Knowledge of IT concepts, including system administration, network and directory management preferred.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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