Laboratory Technician

Job Title: Validation Area Specialist

Job Location: Clayton, North Carolina: 100% Onsite Role

Duration: 1 Year Contract

Schedule: M-F 1st Shift

JOB TITLE: Validation Area Specialist (AP/Aseptic Production)

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.

Roles & Responsibilities:

• 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 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.