CSV Analyst/Technical Writer

Indianapolis-based candidates preferred

W2 ONLY, NO C2C

ONLY want 3-5 years of experience, this is MID LEVEL

Must have TRUE CSV work within IT Systems within a Life Sciences Company

Max Rate: $45/hr W2

Description

The manager views this as someone who is more mid-level with 3-5 years of CSV Lead type experience.

The manager wants someone who comes from CSV in a Life Sciences company. If they have work in R&D groups that would be the best scenario but not 100% needed. Someone who knows GxP and regulations would be great. This is true CSV work within IT systems (not lab equipment). He mentioned Veeva would be great but need someone who has a background in some document management systems. I think he said they us HP ALM. They want someone who has done validation IT from requirements, test scripts and traceability (UAT Testing).

Position Overview:

• Experienced Technical Writer with a focus on system validation, specifically around validating IT systems, to support the large molecule group in documenting validation processes for their Electronic Lab Notebook (ELN) system.

• This role emphasizes the importance of Computer System Validation (CSV) experience and requires the candidate to work independently while engaging with multiple stakeholders, including IT, R&D, Quality & Validation, and Product Owners.

Key Responsibilities:

• Develop and author validation documentation for the large molecule group, including:

• User Requirements Specifications (URS)

• Functional Specifications

• Validation and Test Plans

• IQ/OQ/PQ protocols

• Standard Operating Procedures (SOPs)

• Ensure validation documentation meets GxP and compliance standards.

• Create and execute testing strategies and scripts to support system validation efforts.

• Collaborate with IT, R&D, Quality & Validation, and Product Owners to gather requirements and document workflows.

• Manage structured document control and version management within a Document Management System (DMS).

Qualifications:

• 3+ years of experience in technical writing within a regulated industry (Pharma, Biotech, Animal Health).

• Strong CSV (Computer System Validation) experience, specifically in validating IT systems.

• Experience with system validation, testing protocols, and technical documentation.

• Prior experience with electronic Lab Notebooks (ELN) (Benchling preferred, but any ELN experience acceptable).

• Strong knowledge of GxP, 21 CFR Part 11, and validation documentation processes.

• Ability to work independently while engaging with multiple stakeholders.

• Proficiency in MS Office, Visio, and Document Management Systems (DMS).

Additional Skills & Qualifications

Preferred Qualifications:

• GMP experience is a plus.

• Benchling ELN experience is highly desirable.

• Indianapolis-based candidates preferred

Pay and Benefits

The pay range for this position is $35.00 - $52.00/hr.

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Mar 28, 2025.

About TEKsystems:

We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.