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Validation Specialist

Job Description

As a Validation Specialist, you will perform revalidation on equipment and processes according to approved timelines. You will support validation activities related to changes in existing and new systems, including formulation, sterilization, cleaning, filling, and inspection processes. Your role will involve authoring and reviewing documents to ensure compliance with local, corporate, and regulatory regulations, and collaborating on IQ, OQ, and PQ protocols.

Responsibilities

+ Perform and review revalidation activities.

+ Work and communicate effectively across departments to schedule and perform revalidations.

+ Author and review documents in accordance with local, corporate, and regulatory regulations.

+ Collaborate and review IQ, OQ, and PQ protocols for systems and processes.

+ Support and/or lead the closure of investigations using root cause analysis techniques.

+ Participate in continuous improvement initiatives using cLEAN tools.

+ Ensure executed protocol data is accurate and meets documented acceptance criteria.

+ Manage Change Requests related to revalidation and other validation activities.

+ Author and review validation procedures, specifications, and quality documents.

+ Present and support validation concepts during audits and inspections.

+ Follow all safety and environmental requirements.

Essential Skills

+ Experience in revalidation, validation, and GMP processes.

+ Hands-on experience with production equipment including CIP Skids, autoclaves, depyrogenation tunnels, and washers.

+ Strong data analysis, report generation, and document archival skills.

+ Bachelor's degree in Engineering, Computer Science, or a relevant scientific discipline.

+ Minimum of two years of experience in validation processes within the pharmaceutical or medical device industry.

+ Familiarity with technical documents related to validation efforts.

+ Experience in quality concepts and technical compliance review of validation documents.

Additional Skills & Qualifications

+ Experience with autoclaves, depyrogenation tunnels, filling lines, or washers.

+ Experience in cGMP documentation practices and regulations.

+ Basic computer skills including Microsoft Word and Excel.

+ Knowledge of statistical methods.

+ Strong oral and written communication skills.

+ Experience with validation test equipment like temperature mapping and data loggers.

+ Experience in project team collaboration.

+ Root cause analysis techniques experience.

Work Environment

The role involves supporting revalidation efforts for annual production equipment cycles, with a mix of hands-on work and reporting/data analysis. The position supports a large pharmaceutical manufacturing site with significant growth potential. The work environment encourages collaboration and provides opportunities for project work in a legacy manufacturing site.

Pay and Benefits

The pay range for this position is $35.00 - $40.00/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 onsite position in Clayton,NC.

Application Deadline

This position is anticipated to close on May 16, 2025.

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 [email protected] (%[email protected]) for other accommodation options.