Validation Area Specialist II - Virginia

Novo Nordisk-posted 2 months ago
Full-time • Mid Level
Petersburg, VA
Chemical Manufacturing
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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.
  • Identify and support/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.
  • 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's 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.
  • Experience in one or more core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) preferred.
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred.
  • Knowledge of statistical methods preferred.
  • Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred.
  • Leading pay and annual performance bonus for all positions.
  • All employees enjoy generous paid time off including 14 paid holidays.
  • Health Insurance, Dental Insurance, Vision Insurance - effective day one.
  • Guaranteed 8% 401K contribution plus individual company match option.
  • Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave.
  • Free access to Novo Nordisk-marketed pharmaceutical products.
  • Tuition Assistance.
  • Life & Disability Insurance.
  • Employee Referral Awards.
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