Validation Area Specialist II - Virginia

Role Summary

Validation Area Specialist II - Virginia will plan, manage and perform moderately complex or cross-functional validation activities and projects. The role supports engineers with writing change requests and deviation investigations, and supports validation activities for changes to existing and new systems, focusing on process equipment such as propagation, fermenters, and media sterilizers. Collaboration with IT, metrology, and other stakeholders is essential to ensure quality, cost efficiency, and timely deliverables.

Responsibilities

• Plan, manage & perform validation/revalidation & PSE activities; work across departments to schedule and perform revalidation & PSE assignments
• Identify and support/remediate validation compliance gaps for the department
• Review & approve documents in accordance with local, corporate & regulatory regulations
• Collaborate, review & approve protocols for systems/processes within approved timeframes
• Lead the closure of investigations within approved timeframes using root cause analysis
• Participate in teams to identify root causes of failures and implement corrective actions to prevent recurrence
• Ensure executed protocol data is accurate and meets acceptance criteria
• Responsible for Change Requests related to revalidation & other validation activities
• Create, review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Present and support validation concepts & approaches during audits & inspections
• Lead & manage validation projects and change control processes; identify opportunities for improvement
• Write, review specifications, procedures, & other documents to maintain validated state of equipment & processes
• Coach, mentor and train junior level specialists
• Operate in alignment with NNWay, demonstrating a Quality & lean mindset
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Qualifications

• Bachelor's Degree in engineering, pharmaceutical sciences or related field; minimum five (5) years of related validation experience in pharmaceutical or medical device industry
• Or: Associate’s Degree with minimum seven (7) years of relevant validation experience
• Or: High School Diploma or equivalent with minimum nine (9) years of relevant validation experience
• Experience in quality concepts including technical & compliance review of validation & quality documents
• Experience in core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) preferred
• cGMP documentation practices & regulations required
• Basic computer skills (Microsoft Word, Excel) preferred
• Knowledge of statistical methods preferred
• Strong oral & written communication skills required
• Experience with validation test equipment including temperature mapping equipment preferred
• Experience working in cross-functional teams
• Demonstrated experience using root-cause analysis techniques
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising work plans for complex problems

Skills

• Validation planning and project management
• Root cause analysis and problem solving
• Technical writing and document control
• Cross-functional collaboration
• Audits and inspections support
• Change control and deviation management

Education

• As listed in Qualifications

Additional Requirements

• Ability to travel up to 10% of the time