Validation Area Specialist II - Virginia

Role Summary

Location: Petersburg, Virginia. Plan, manage and perform moderately complex or cross-functional validation activities and projects. Support engineers with writing change requests and deviation investigations. Support validation activities associated with changes to existing and new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Collaborate with IT, metrology and other key stakeholders to ensure quality, cost and timely completion of all deliverables.

Responsibilities

• 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’s) 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
• Other duties as assigned

Qualifications

• Required: Bachelor's Degree in engineering, pharmaceutical sciences or related field from an accredited university, and a minimum of five (5) years of related validation experience in pharmaceutical or medical device industry
• Preferred: Associate’s Degree in engineering, pharmaceutical sciences or related field from an accredited college or university with a minimum of seven (7) years of relevant validation experience in pharmaceutical or medical device industry
• Preferred: High School Diploma or equivalent with a minimum of nine (9) years of relevant validation 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 (equipment, sterilization, cleaning, process clean & black utilities or computer validation)
• Required: 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
• Required: Strong oral & written communication skills
• Preferred: Experience with validation test equipment including temperature mapping equipment (e.g., Ellab Validator)
• Preferred: Experience working in cross functional teams
• Required: 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

Skills

• Root-cause analysis techniques
• Cross-functional collaboration
• Validation document review and quality concepts
• Planning and project management
• Strong verbal and written communication
• Basic computer skills (Word, Excel)
• Statistical methods knowledge
• Experience with validation test equipment (temperature mapping)

Education

• Bachelor's Degree in engineering, pharmaceutical sciences or related field required
• Alternative: Associate’s Degree with 7 years of related validation experience in lieu of BS
• Alternative: High School Diploma or equivalent with 9 years of related validation experience in lieu of BS

Additional Requirements

• Travel up to 10% of the time