What are the responsibilities and job description for the Validation Engineer II - Virginia position at BioSpace?
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.
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.