Validation Area Specialist I

Job Title: Validation Area Specialist I

Location: Clayton, NC (Onsite)

Duration: 12+ months (Possibilities of Extension) 

Job Description

Job Purpose:

• Perform revalidation on equipment/processes per approved timelines.
• Support validation activities associated with changes to existing & new systems.
• Processes include formulation, sterilization, cleaning, filling & inspection.

Essential Functions:

• 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.
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset.
• Other accountabilities, as assigned.

Qualifications:

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

Physical Requirements:

• Physical Requirement Details Ability to work in an open office environment with the possibility of frequent distraction.