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Our client, an expanding biopharmaceutical company, is seeking a Validation Specialist to join their team. They will primarily be responsible for performing revalidation on equipment/processes per approved timelines, supporting validation activities associated with changes to existing and new systems, and processes including formulation, sterilization, cleaning, filling & inspection.

+ Perform & review revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidations.

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

+ Collaborate and review IQ, OQ & PQ protocols for systems/processes per approved timeframes.

+ Support and/or lead the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures.

+ Participate in continuous improvement initiatives using cLEAN tools and methodology

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

+ Responsible for Change Requests (CR’s) related to revalidation & other validation activities for AP.

+ Author and review validation procedures, specifications & quality documents for accuracy & compliance.

+ Presentation & support for validation concepts & approaches with audits & inspections.

+ Follow all safety & environmental requirements in the performance of duties.

Qualifications

Bachelor's Degree in Engineering, Computer Science, or applicable scientific or technical degree required.

Minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required.

Experience in quality concepts including technical & compliance review of validation & quality documents preferred.

Experience in one or more core validation areas (sterilization, cleaning, process or computer validation) preferred.

Experience in cGMP documentation practices & regulations preferred.

Basic computer skills including experience in the use of Microsoft word, Excel, etc. preferred.

Knowledge of statistical methods preferred.

Strong oral & written communication skills preferred.

Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator) preferred.

Experience in project team collaboration & support preferred.

At least one (1) year of demonstrated experience using root-cause analysis techniques to solve problems preferred.

Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus.

Experience Level

Intermediate Level

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 14, 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.