Csv Specialist

Actalent; United States; Hybrid; USD 69,000 - 103,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Time Off (PTO)

Job summary

Actalent is seeking a CSV Specialist to author validation documentation for remediation of 32 legacy GxP computerized systems. You will write and execute IQ/OQ/PQ protocols, compose SOPs, and prepare a Validation Summary Report under supervision.

The role begins onsite for one month in Miami, with potential remote work thereafter. You should have 5+ years in pharma/biotech, strong technical writing, and familiarity with CFR Part 11 and ALCOA+ data integrity.

Qualifications

• 5+ years in pharma/biotech/medical device with at least 1 year in computerised system validation.
• Experience writing/executing IQ/OQ/PQ or verification protocols.
• Knowledge of 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity.
• Hands-on validation/remediation of lab or manufacturing systems.

Responsibilities

• Author IQ and verification protocols for remediated controls (access, audit trails, EHR, data integrity).
• Execute protocols, document evidence, address deviations.
• Draft system SOPs and assist IT with admin SOPs.
• Contribute to privilege matrices, configuration specs and data controls.
• Prepare final Validation Summary Report for all 32 systems at project end.
• Revise documents based on QA feedback, follow SOPs and document control.

Skills

Pharma/biotech exp

IQ/OQ/PQ protocols

21 CFR Part 11/EU Annex 11

Data integrity (ALCOA+)

Lab/manufacturing system validation

Education

Bachelor's degree in science/engineering/IT

Tools

LIMS

Chromatography data systems

MES

ERP systems

Job description

Job Title: CSV Specialist

Job Description

The CSV Specialist is responsible for authoring validation documentation for the remediation of 32 legacy GxP computerized systems. Working under the guidance of an experienced Software Quality Engineer, the specialist writes and executes protocols, composes SOPs, and prepares a comprehensive Validation Summary Report for all systems.

Responsibilities

• Author Installation Qualification (IQ) and verification protocols to test remediated controls, including user access, audit trails, electronic records, and data integrity.
• Execute protocols, document objective evidence, and address any deviations.
• Compose system operational SOPs and assist the IT Specialist with system administration SOPs.
• Contribute to the development of privilege matrices, configuration specifications, and data integrity controls.
• Prepare a final Validation Summary Report encompassing all 32 systems at the project's conclusion.
• Revise documents based on feedback from QA reviewers.
• Adhere to SOPs, templates, and document control processes, maintaining good documentation practices.

Essential Skills

• 5+ years of experience in the pharmaceutical, biotech, or medical device industry, with at least 1 year in computerized system validation.
• Hands-on experience in writing and executing IQ, OQ, PQ, or verification protocols.
• Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
• Experience in validating or remediating laboratory or manufacturing systems such as LIMS, chromatography data systems, MES, or ERP.
• Strong technical writing skills and attention to detail.

Additional Skills & Qualifications

• Experience in remediating legacy systems post-audit or gap assessment.
• Experience in supporting FDA inspections or client audits.
• Bachelor's degree in a scientific, engineering, or IT field.

Work Environment

The role begins with an onsite requirement for the first month, after which, once the initial documentation is complete, there is the flexibility to transition to remote work. This opportunity allows you to take on a complete project with a growing firm.

Job Type & Location

This is a Contract position based out of Miami, FL.

Pay and Benefits

The pay range for this position is $50.00 - $75.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

This position is anticipated to close on Nov 17, 2026.

Workplace Type

This is a hybrid position in Miami,FL.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.