Job Title: CSV SpecialistJob DescriptionThe 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 EnvironmentThe 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 & LocationThis is a Contract position based out of Miami, FL. Pay and BenefitsThe 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 job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Miami, FL. Application DeadlineThis position is anticipated to close on Nov 17, 2026. Workplace TypeThis 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.