Validation Engineer II - Virginia

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET's SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

• 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

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Responsible perform validation activities such as DQ, IQ, OQ, PQ and Requalification. Act as a validation Subject Matter Expert (SME); ensuring a science and risk-based validation approach on defining strategy for projects. Responsible for ensuring that the validated state of the facility, utilities, systems, and equipment are maintained.

Relationships

Reports to Manager, Director.

Essential Functions

• Author validation plans and review/approve validation documents to ensure that requirements are met
• Ensure adherence to quality and regulatory requirements for validation of facilities, utilities, computerized equipment, laboratory equipment, as required
• Present validation documents and strategy in internal audits and external inspections
• Maintain regulatory documentation as it relates to changes in the validated state
• Perform revalidations, system evaluations, and continued process verification schedules
• Independently analyze and interpret data with limited consultation with supervisor, make independent tactical decisions based on data, and develop project strategies with consultation with supervisor
• Represent Validation on cross-functional teams (Engineering, Technical Support and Quality groups)
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Ability to travel up to 10% of the time. % can change on a case-by-case basis based on the role.

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required with a minimum of five (5) years of validation experience in a cGMP regulated industry required
• In lieu of BS degree + five (5) years of validation experience in a cGMP regulated industry, may consider an Associate's degree in Life Sciences, Engineering, or a relevant field of study from an accredited university with a minimum of seven (7) years of validation experience in a cGMP regulated industry required
• Demonstrated understanding of GEP and Validation concepts, international cGMP regulations, and industry standards pertaining to the technical and verification requirements for facilities, utilities, systems and equipment required
• Excellent communication skills; both written and verbal required
• Demonstrated ability to be self-motivated, trustworthy, work in a high-paced environment, team oriented, innovative, and committed required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.