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Validation Engineer II - Virginia
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BioSpace 6 days ago Be among the first 25 applicants Join to apply for the
Validation Engineer II - Virginia
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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 includes leading pay and annual performance bonus for all positions, generous paid time off including 14 paid holidays, health/dental/vision insurance effective day one, 8% 401K contributions with company match, family-focused benefits, tuition assistance, life & disability insurance, referral awards, and more. The Position is described below with responsibilities, relationships, essential functions, and qualifications. Responsibilities
Responsible to perform validation activities such as DQ, IQ, OQ, PQ and Requalification. Act as a Validation Subject Matter Expert (SME); ensure a science and risk-based validation approach and define strategy for projects. Ensure that the validated state of the facility, utilities, systems, and equipment is maintained. 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 supervision, make independent tactical decisions, and develop project strategies with supervisory input. Represent Validation on cross-functional teams (Engineering, Technical Support and Quality). Follow all safety & environmental requirements in the performance of duties. Other duties as assigned. 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. Qualifications
Bachelor’s Degree in Life Sciences, Engineering, or a relevant field from an accredited university with a minimum of five (5) years of validation experience in a cGMP regulated industry (required). In lieu of a BS degree, an Associate’s degree 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 for facilities, utilities, systems and equipment. Excellent written and verbal communication skills. Self-motivated, trustworthy, able to work in a high-paced environment, team-oriented, innovative, and committed. We commit to an inclusive recruitment process and equality of opportunity for all applicants. Equal Opportunity
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by law. If you need special assistance or reasonable accommodation to apply, please call 1-855-411-5290. Locations & Other Roles
Colonial Heights, VA: $69,700.00-$109,700.00 (2 weeks ago) Hopewell, VA: $95,000.00-$142,600.00 (5 months ago) Civil Project Engineer - Waste & Recycling (Richmond, VA: $79,000.00-$95,000.00, 2 weeks ago) Drinking Water Associate Process Engineer (Richmond, VA: $95,000.00-$135,000.00, 1 day ago) Analyst II, Process Engineer - Supply Chain (Sutherland, VA: $80,000.00-$120,000.00, 1 week ago) Transportation Project Engineer - Entry Level
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Join to apply for the
Validation Engineer II - Virginia
role at
BioSpace 6 days ago Be among the first 25 applicants Join to apply for the
Validation Engineer II - Virginia
role 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 includes leading pay and annual performance bonus for all positions, generous paid time off including 14 paid holidays, health/dental/vision insurance effective day one, 8% 401K contributions with company match, family-focused benefits, tuition assistance, life & disability insurance, referral awards, and more. The Position is described below with responsibilities, relationships, essential functions, and qualifications. Responsibilities
Responsible to perform validation activities such as DQ, IQ, OQ, PQ and Requalification. Act as a Validation Subject Matter Expert (SME); ensure a science and risk-based validation approach and define strategy for projects. Ensure that the validated state of the facility, utilities, systems, and equipment is maintained. 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 supervision, make independent tactical decisions, and develop project strategies with supervisory input. Represent Validation on cross-functional teams (Engineering, Technical Support and Quality). Follow all safety & environmental requirements in the performance of duties. Other duties as assigned. 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. Qualifications
Bachelor’s Degree in Life Sciences, Engineering, or a relevant field from an accredited university with a minimum of five (5) years of validation experience in a cGMP regulated industry (required). In lieu of a BS degree, an Associate’s degree 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 for facilities, utilities, systems and equipment. Excellent written and verbal communication skills. Self-motivated, trustworthy, able to work in a high-paced environment, team-oriented, innovative, and committed. We commit to an inclusive recruitment process and equality of opportunity for all applicants. Equal Opportunity
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by law. If you need special assistance or reasonable accommodation to apply, please call 1-855-411-5290. Locations & Other Roles
Colonial Heights, VA: $69,700.00-$109,700.00 (2 weeks ago) Hopewell, VA: $95,000.00-$142,600.00 (5 months ago) Civil Project Engineer - Waste & Recycling (Richmond, VA: $79,000.00-$95,000.00, 2 weeks ago) Drinking Water Associate Process Engineer (Richmond, VA: $95,000.00-$135,000.00, 1 day ago) Analyst II, Process Engineer - Supply Chain (Sutherland, VA: $80,000.00-$120,000.00, 1 week ago) Transportation Project Engineer - Entry Level
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