361800BR
1月 17, 2023
USA
About the Role
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Computer Systems Validation (CSV) Engineer will be responsible for the execution of non-IT GMP system CSV and associated Data Integrity activities at the site.
Your responsibilities include, but are not limited to:
• Execution of CSV/Data Integrity activities associated with GMP manufacturing and laboratory instruments/equipment, utilities, and facilities.
• Develop, execute, review, and approve validation protocols and reports and coordinate CSV work execution with various departments and contractors.
• Coordinate/manage multiple small and large CSV/Data Integrity projects simultaneously.
• Assist with development and implementation of standard practices and procedures for the computer system validation while ensuring alignment with the global CSV requirements. Includes performing gap analyses of the current site requirements and completed CSV activities. Execution of any remediation actions resulting from the gap assessments.
• Execute and/or oversee work required to CSV activities and Qualification activities for pharmaceutical equipment, GMP utilities, control systems, process and computer system including coordinating test work with various departments.
• Act as a CSV/Data Integrity subject matter expert (SME)/representative on project teams. Lead CSV deviation investigations to resolve discrepancies. Act as the SME for equipment related CSV requests during internal and external regulatory inspections.
• Use expertise to develop appropriate CSV/Data Integrity strategies for GMP equipment/processes that are in accordance with company policies; ensure regulatory compliance and meet business needs. Includes preparation of and/or input into the associated Validation/Qualification Master Plans, develop/review/approve/execute validation and qualification protocols and periodic system reviews, analysis of data and develop/review/approve validation summary reports.
• Support the creation, implementation, and maintenance of the site CSV/Data Integrity compliance program, strategy and provides the necessary training. Assesses and interprets global, FDA and other predicate rules (regulations) and their application to the CSV program and Data Integrity.
The pay range for this position at commencement of employment is expected to be between $118,400.00 and $177,600.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
https://www.youtube.com/watch?v=ggbnzRY9z8w
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Computer Systems Validation (CSV) Engineer will be responsible for the execution of non-IT GMP system CSV and associated Data Integrity activities at the site.
Your responsibilities include, but are not limited to:
• Execution of CSV/Data Integrity activities associated with GMP manufacturing and laboratory instruments/equipment, utilities, and facilities.
• Develop, execute, review, and approve validation protocols and reports and coordinate CSV work execution with various departments and contractors.
• Coordinate/manage multiple small and large CSV/Data Integrity projects simultaneously.
• Assist with development and implementation of standard practices and procedures for the computer system validation while ensuring alignment with the global CSV requirements. Includes performing gap analyses of the current site requirements and completed CSV activities. Execution of any remediation actions resulting from the gap assessments.
• Execute and/or oversee work required to CSV activities and Qualification activities for pharmaceutical equipment, GMP utilities, control systems, process and computer system including coordinating test work with various departments.
• Act as a CSV/Data Integrity subject matter expert (SME)/representative on project teams. Lead CSV deviation investigations to resolve discrepancies. Act as the SME for equipment related CSV requests during internal and external regulatory inspections.
• Use expertise to develop appropriate CSV/Data Integrity strategies for GMP equipment/processes that are in accordance with company policies; ensure regulatory compliance and meet business needs. Includes preparation of and/or input into the associated Validation/Qualification Master Plans, develop/review/approve/execute validation and qualification protocols and periodic system reviews, analysis of data and develop/review/approve validation summary reports.
• Support the creation, implementation, and maintenance of the site CSV/Data Integrity compliance program, strategy and provides the necessary training. Assesses and interprets global, FDA and other predicate rules (regulations) and their application to the CSV program and Data Integrity.
The pay range for this position at commencement of employment is expected to be between $118,400.00 and $177,600.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
https://www.youtube.com/watch?v=ggbnzRY9z8w
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Role Requirements
What you’ll bring to the role:
Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field.
3-5 years pharmaceutical industry experience required. 2-5 years of Facilities, Utilities, Equipment and Analytical Instruments Qualification experience or applicable experience in a related area in the pharmaceutical industry.
Thorough knowledge of computer system validation (CSV) requirements defined by applicable Novartis requirements, health authorities and/or industry groups.
Knowledgeable in cGMP and regulatory requirements. Strong technical writing skills for generating high quality protocols & technical reports. Capable of working cross-functionally, a team player. Good project management skills, decision-making ability. Good communication and negotiations skills. Must be able to work independently with a minimal supervision. Good knowledge of regulatory requirements (FDA, EMEA, ICH).
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field.
3-5 years pharmaceutical industry experience required. 2-5 years of Facilities, Utilities, Equipment and Analytical Instruments Qualification experience or applicable experience in a related area in the pharmaceutical industry.
Thorough knowledge of computer system validation (CSV) requirements defined by applicable Novartis requirements, health authorities and/or industry groups.
Knowledgeable in cGMP and regulatory requirements. Strong technical writing skills for generating high quality protocols & technical reports. Capable of working cross-functionally, a team player. Good project management skills, decision-making ability. Good communication and negotiations skills. Must be able to work independently with a minimal supervision. Good knowledge of regulatory requirements (FDA, EMEA, ICH).
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
AAA USA Inc.
Technical Operations
Full Time
Regular
No
