Associate Validation Engineer VA

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 ETs 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 14weeks 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. Responsible for ensuring that the validated state of the facility utilities systems and equipment are maintained.

***Please note we are open to hiring at more senior level commensurate with experience***

Relationships

Reports to Sr. Manager

Essential Functions

• Perform temperature mapping of systems in all process conditions (ambient ultra-cold etc.) as well as perform simple troubleshooting related to temperature mapping and controlled chambers
• Support leadership in performing equipment installation qualification operational qualification performance qualification and requalification in accordance with validation procedures
• Responsible for generating protocols executing validations analyzing data generating reports identifying validation deviations resolving validation deviations with support from Sr Project Manager and engagingin investigations to identify root causes and defining corrective/preventative actions
• Assist with validation documentation such as URS risk assessments design reviews and reports when necessary
• Maintain training programs for validation contractors with support from SME as well as deploy test equipment training to equipment users
• Maintain system evaluations to ensure systems are staying within the validated state
• Maintain validation and process engineering test equipment within computerized maintenance system and ensure test equipment is calibrated timely and always readily available
• Work on cross-functional teams with Validation Engineering Manufacturing Project Management Quality Control Facilities and Quality Assurance
• 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

• Bachelors Degree in Life Science Engineering or relevant field of study from an accredited required
• In lieu of Bachelors Degree may consider Associates Degree in Life Sciences Engineering or a relevant field of study from an accredited university required and a minimum of two (2) years of validation experience in a cGMP regulated industry required
• Demonstrated ability to follow routine work instructions for new and ongoing projects and assignments 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.

Were not your typical healthcare 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.