Validation Area Specialist III - Virginia

Novo Nordisk•Petersburg, VA

About The Position

Serve as the subject matter expert (SME) for planning, managing, and performing high-complexity validation activities and projects. Support engineers with change requests and deviation investigations and writing, and support validation activities associated with changes to existing and new systems. Supported process equipment includes propagation, fermenters, media sterilizers, and supporting equipment. Coordinate with IT, metrology, and other stakeholders to ensure quality, cost, and timely completion of deliverables. Mentor junior team members.

Requirements

Bachelor's degree in engineering, pharmaceutical sciences, or a related field from an accredited university and at least 7 years of relevant validation experience in the pharmaceutical or medical device industry; alternatively, an associate's degree in a related field and at least 9 years of relevant experience; or a high school diploma or equivalent and at least 11 years of relevant experience.
Experience in quality concepts, including technical and compliance review of validation and quality documents.
Experience in one or more core validation areas: equipment, sterilization, cleaning, process clean and black utilities, or computer validation.
Experience with cGMP documentation practices and regulations.
Ability to work and communicate effectively across multiple departments to schedule and perform revalidation and PSE assignments.
Strong oral and written communication skills.
Demonstrated experience using root-cause analysis techniques to solve problems.
Expertise in planning and organizing, managing execution, checking results, and revising work plans for complex problems addressed by cross-functional teams.
Ability to work in an open-office environment with the possibility of frequent distraction.
Ability to travel up to 10% of the time; this may change on a case-by-case basis.

Nice To Haves

Basic computer skills, including experience using Microsoft Word and Excel.
Knowledge of statistical methods.
Experience with validation test equipment, including temperature mapping equipment such as Ellab Validator.

Responsibilities

Provide SME-level knowledge and guidance to team members and stakeholders on validation activities, initiatives, and projects.
Resolve validation-related issues through actions that enable rapid, effective decision-making, and communicate decisions clearly and promptly.
Perform, review, and approve validation, revalidation, and PSE activities.
Identify and support or perform remediation of validation compliance gaps for the department.
Review and approve documents in accordance with local, corporate, and regulatory requirements.
Collaborate on, review, and approve protocols for systems and processes within approved timeframes.
Lead investigation closure within approved timeframes using root-cause analysis techniques.
Participate in teams to identify root causes of failures and implement corrective actions to prevent recurrence.
Ensure executed protocol data is reviewed accurately and meets documented acceptance criteria.
Handle deviations related to revalidation and other validation activities.
Manage change requests related to revalidation and other validation activities.
Review and approve validation procedures, specifications, and quality documents for accuracy and compliance.
Present and support validation concepts and approaches during audits and inspections.
Translate validation procedural requirements into practical workflows to guide project execution.
Identify and implement improvements that support risk-based validation execution at the site.
Build cross-functional relationships with Novo Nordisk project organization and validation project contributors locally and abroad.
Work in alignment with NNWay, demonstrating a Quality and cLEAN® Mindset.
Follow safety and environmental requirements while performing duties.
Perform other duties as assigned.

Benefits

Leading pay and annual performance bonus for all positions.
Generous paid time off, including 14 paid holidays.
Health insurance, dental insurance, and vision insurance effective day one.
Guaranteed 8% 401(k) contribution plus an individual company match option.
Family-focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave.
Free access to Novo Nordisk-marketed pharmaceutical products.
Tuition assistance.
Life and disability insurance.
Employee referral awards.
Opportunities, resources, and mentorship to support career growth.