Validation Area Specialist II - Virginia

Role Summary

Validation Area Specialist II - Virginia

Responsibilities

• Plan, manage & perform moderately complex or cross-functional validation activities & projects. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.
• Perform, review & approve validation/revalidation & PSE activities. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments
• Identifies and supports/performs remediation of validation compliance gaps for the department
• Review & approve documents in accordance with local, corporate & regulatory regulations
• Collaborate, review & approve protocols for systems/processes per approved timeframes
• 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
• Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
• Responsible for Change Requests (CR‚Äôs) related to revalidation & other validation activities
• Create, review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Responsible for presentation & support for validation concepts & approaches with audits & inspections
• Lead & manage relevant validation projects and change control process and identify opportunities for improvement
• Write, review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
• Coach, mentor and train junior level specialists
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN Mindset
• Follow all safety & environmental requirements in the performance of duties

Qualifications

• Bachelor's Degree in engineering, pharmaceutical sciences or related field of study from an accredited university required and a minimum of five (5) years of related validation experience in pharmaceutical or medical device industry
• In lieu of BS degree + five (5) years of experience, may consider an Associate‚Äôs Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university with a minimum of seven (7) years of relevant validation experience in pharmaceutical or medical device industry
• In lieu of BS degree + five (5) years of experience, may consider a High School Diploma or equivalent with a minimum of nine (9) years of relevant validation experience in pharmaceutical or medical device industry
• Experience in quality concepts including technical & compliance review of validation & quality documents required
• Experience in one or more core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) preferred
• Experience in cGMP documentation practices & regulations required
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Knowledge of statistical methods preferred
• Strong oral & written communication skills required
• Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
• Experience working in cross functional teams
• Demonstrated experience using root-cause analysis techniques to solve problems required
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus

Skills

• Root-cause analysis
• Validation planning and execution
• Cross-functional collaboration
• Documentation and compliance
• Technical writing and communication

Education

• Bachelor's Degree in engineering, pharmaceutical sciences or related field

Additional Requirements

• Physical Requirements: Ability to work in an open office environment with the possibility of frequent distraction. Travel up to 10% of the time.