Validation Specialist

Job Title: Validation Specialist

Job Description

The primary responsibility of this role is to provide and lead validation services required for the successful delivery of highly automated warehouse processes and projects. These projects, locally called 'Intralogistics', integrate Automated Storage and Retrieval Systems (ASRS), high-density warehouses, automated conveyors, Automated Guided Vehicles (AGVs)/Automated Mobile Robots (AMRs), and more, to fully automate material handling flows across the FFEx site.

Responsibilities

• Provide validation and technical support through the preparation, execution, data analysis, and report writing for IV, OV, and PV protocols.
• Take ownership of Change Requests (CRs) related to project validation responsibilities.
• Perform compliance and technical reviews/approvals of protocols and protocol data.
• Author project quality master plans (PQMPs), validation plans (VPLs), and other key validation documentation.
• Author and execute assigned IV, OV, and PV protocols for direct impact systems/processes per approved timeframes, independently.
• Ensure compliance of executed validation protocols with local, corporate, and regulatory regulations.
• Lead validation failure investigations and non-conformities using root cause analysis techniques.
• Create and modify existing validation procedures and configuration item lists (CILs) as required.
• Write and review specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes.
• Participate in FAT, SAT commissioning efforts for equipment, automation systems, and processes, and transition into the ownership role for validation efforts.
• Identify process improvements before equipment, systems, or processes are placed under change control during validation.
• Oversee budget and contractor scheduling as needed.
• Lead validation activities assigned by the overall project manager.
• Fulfill other accountabilities as assigned.

Essential Skills

• Minimum of seven years of experience in validation or quality-related discipline within a pharmaceutical environment.
• Minimum of 3-5 years’ experience with robotics, automation, and SAP preferred.
• Experience with regulatory requirements and industry standards for pharmaceutical and/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA and ICH guidance documents.
• Demonstrated experience using root-cause analysis techniques to solve problems.

Job Type & Location

This is a Contract position based out of Raleigh, NC.

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

This is a fully onsite position in Raleigh,NC.

This position is anticipated to close on Jan 31, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $75