Address
Form of workAbout the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' Sandoz!
As the Specialist, Engineering Compliance, you will be responsible for establishing technical quality systems and manufacturing support related to current Good Manufacturing Practices (cGMP) policies and guidelines across engineering and HSE functions. This requires a thorough understanding of HSE, manufacturing systems, cGMPs, SOPs, preventive maintenance, machine safety, and EDMS procedures. The role will also support the Engineering and HSE Department in Information Governance Management (IGM), an Business Information Management for the site. You will be responsible for site oversight of non-IT IGM and Business Information Management while supporting GxP activities in the Engineering department. And you will administer HSE and Quality Systems/ Processes including documentation and monitoring of actions.
Your additional responsibilities include, but are not limited to:
• Administration of technical quality systems and best practices.
• Launch and revise manufacturing and engineering documents in and through the EDMS system.
• Support technical & engineering and HSE related investigations.
• Lead and or participate in ad hoc teams and committees to support dynamic business needs. Interact in cross functional teams.
• Interface with Engineering management to report on project and program milestones and to present project needs.
• Work with management team to implement new or revise processes and procedures. Participate in efficiency initiatives, OEE activities, and HSE improvements.
• Lead contract employees and/or consultants on tasks.
• Work within production areas that require special gowning requirements and/or certification, (i.e. Warehouse, Chemical Dispensing, Compounding, Filling and Packaging).
• Support managing department compliance activities such as department training, CAPA management, and SOP revision.
• Ability to lift 5Kg to waist height.
• Responsibilities include gowning and going into production floor (walking, standing, and bending).
• Travel between Hicksville and Melville sites.
• Adherence to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and departmental, plant, and corporate Quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
The pay range for this position at commencement of employment is expected to be between $26.10 and $39.18/hour; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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.
Role Requirements
What you'll bring to the role:
• Minimum of a bachelor's degree in engineering or other technical/science related discipline. In lieu of a bachelor's degree, a minimum of 5 years of relevant pharmaceutical experience.
• Minimum 2 years of experience working within a regulated industry
• Ability to lift a minimum of 5Kg to waist height.
• • Excellent oral and written communication skills.
• Proficient in advanced math skills
• Excellent computer (Microsoft Suite) and analytical skills
• Ability to travel between Hicksville and Melville sites.
• Ability for limited travel outside of plant locations (1-3 times/year).
• To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants. Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool.
#Sandoz
EEO Statement
We 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.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' Sandoz!
As the Specialist, Engineering Compliance, you will be responsible for establishing technical quality systems and manufacturing support related to current Good Manufacturing Practices (cGMP) policies and guidelines across engineering and HSE functions. This requires a thorough understanding of HSE, manufacturing systems, cGMPs, SOPs, preventive maintenance, machine safety, and EDMS procedures. The role will also support the Engineering and HSE Department in Information Governance Management (IGM), an Business Information Management for the site. You will be responsible for site oversight of non-IT IGM and Business Information Management while supporting GxP activities in the Engineering department. And you will administer HSE and Quality Systems/ Processes including documentation and monitoring of actions.
Your additional responsibilities include, but are not limited to:
• Administration of technical quality systems and best practices.
• Launch and revise manufacturing and engineering documents in and through the EDMS system.
• Support technical & engineering and HSE related investigations.
• Lead and or participate in ad hoc teams and committees to support dynamic business needs. Interact in cross functional teams.
• Interface with Engineering management to report on project and program milestones and to present project needs.
• Work with management team to implement new or revise processes and procedures. Participate in efficiency initiatives, OEE activities, and HSE improvements.
• Lead contract employees and/or consultants on tasks.
• Work within production areas that require special gowning requirements and/or certification, (i.e. Warehouse, Chemical Dispensing, Compounding, Filling and Packaging).
• Support managing department compliance activities such as department training, CAPA management, and SOP revision.
• Ability to lift 5Kg to waist height.
• Responsibilities include gowning and going into production floor (walking, standing, and bending).
• Travel between Hicksville and Melville sites.
• Adherence to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and departmental, plant, and corporate Quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
The pay range for this position at commencement of employment is expected to be between $26.10 and $39.18/hour; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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.
Role Requirements
What you'll bring to the role:
• Minimum of a bachelor's degree in engineering or other technical/science related discipline. In lieu of a bachelor's degree, a minimum of 5 years of relevant pharmaceutical experience.
• Minimum 2 years of experience working within a regulated industry
• Ability to lift a minimum of 5Kg to waist height.
• • Excellent oral and written communication skills.
• Proficient in advanced math skills
• Excellent computer (Microsoft Suite) and analytical skills
• Ability to travel between Hicksville and Melville sites.
• Ability for limited travel outside of plant locations (1-3 times/year).
• To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants. Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool.
#Sandoz
EEO Statement
We 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.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
