Validation Area Specialist I/II - SDF

Quick Facts

Plan, manage & perform low to moderately complex validation projects for pharmaceutical systems and equipment; coordinate with IT and key stakeholders to ensure quality and timely completion.

Description

Perform, review & approve validation/revalidation activities. Support engineers with change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing and new systems as assigned, including equipment such as propagation, fermenters, media sterilizers and supporting equipment. Collaborate and coordinate with IT, Metrology and other key stakeholders to ensure quality, cost effectiveness aligned with budget targets and timely completion of deliverables.

Responsibilities (Essential Functions)

• Perform, review & approve validation/revalidation; schedule and execute validation assignments across departments
• Review and approve documents in accordance with local, corporate & regulatory regulations
• Collaborate to review and approve protocols for systems/processes within approved timeframes
• Identify root causes of failures and implement corrective actions to prevent reoccurrence; support investigation closure per approved timeframes using root cause analysis techniques
• Ensure executed protocol data is accurate and meets documented acceptance criteria
• Responsible for Change Requests related to revalidation and other validation activities as assigned
• Review and approve validation procedures, specifications and quality documents for accuracy and compliance
• Provide support for validation concepts and approaches with audits and inspections as assigned
• Support change control process and identify opportunities for improvements
• Author and review validation procedures, specifications and quality documents
• Operate in alignment with NNWay and a Quality & cLEAN mindset
• Follow all safety & environmental requirements

Benefits

• Leading pay and annual performance bonus
• 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

Requirements

• Bachelor’s degree in engineering, pharmaceutical sciences or related field from an accredited university required
• Minimum 2 years of validation related discipline experience in pharmaceutical or medical device industry required
• In lieu of BS degree + 2 years experience: consider Associate’s degree with minimum 4 years relevant validation experience
• In lieu of BS degree with 2 years experience: consider High School Diploma/equivalent with minimum 6 years relevant validation experience

Preferred Qualifications

• Experience with quality concepts including technical & compliance review of validation and quality documents
• Experience in core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation)
• Experience in cGMP documentation practices & regulations
• Basic computer skills (Microsoft Word, Excel)
• Knowledge of statistical methods
• Strong oral and written communication skills
• Experience with validation test equipment including temperature mapping (e.g., Ellab Validator)
• Experience working with cross functional teams
• Root-cause analysis problem-solving knowledge
• Demonstrated expertise in planning/organizing and managing execution/checking results for complex cross-functional problems