Quality Engineer (Hybrid) - Nestle
Waltham, MA
About the Job
At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.
At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.
Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.
Position Summary:
Reporting to the Manager, Facilities, Engineering and Validation, the Quality Engineer role includes aspects of traditional Validation, Facilities, and Operations Engineering disciplines in a GMP environment. You will be involved in supporting and maintaining facilities and equipment ensuring regulatory compliance at all times to ensure the release of VOWST to serve at risk populations. Please note this role is a Hybrid position.
This is an exciting opportunity for anyone who excels at active, and creative problem solving. While this is a GMP environment, it is not your typical experience, our program requiring a unique opportunity to apply GMP principles to an area as yet unregulated by the FDA. Our unique product provides the opportunity to grow within a cutting edge GMP program, setting the benchmark for a new industry.
This role requires not only a strong application of GMP principles, but curiosity and attention to details in a fast-paced environment. You will have the opportunity to be a key contributor to the program as well as grow with the organization as it brings a pioneering product to the market. Due to the unique nature of our product, this is not a cookie cutter assembly of requirements, and requires an excitement and attention to detail to understand the unique biology of our product, and the controls necessary to support it. If you’re excited about the opportunity to learn and apply Engineering skills to a new product, and to grow with our organization, this may be the right place for you.
Key Responsibilities:
• Perform GMP commissioning and qualification activities including the drafting and execution of Installation, Operation, and Performance Qualification and Requalification Protocols.
• Administrate the Validation Management platform and schedule validation events with equipment stakeholders.
• Coordinate and execute calibration and planned maintenance activities on facility and laboratory equipment. Facilitate third-party execution of calibration and planned maintenance activities.
• Work with technical leads and third-party subject matter experts to troubleshoot facility and analytical equipment.
• Operate the Computerized Maintenance Management System (CMMS) for calibration, maintenance, and work order management of equipment and systems.
• Support and lead quality efforts including the drafting and implementation of change controls, deviations, CAPAs, and regulatory filings.
• Draft, revise, and own documents in the quality management system including SOPs, forms, lists, etc.
• Draft and revise engineering documents including specifications, equipment layout diagrams, and PIDs.
• Support and lead interdisciplinary projects to procure, install, commission, and qualify equipment and facility improvements on-time and on-budget.
• Effectively collaborate with cross-functional teams to develop and implement engineering solutions that enhance efficiency, reliability, and compliance of laboratory and Donor facilities.
• The travel requirement for the Engineer II, FEV role is < 20%.
Experience and Education Requirements:
• Bachelor’s degree in a related engineering discipline or equivalent work experience.
• 3+ years of experience in the pharmaceutical industry.
• Strong knowledge of GMP regulations.
• Familiarity with Blue Mountain Regulatory Asset Management or similar platform preferred.
• Familiarity with Kneat Gx or similar platform preferred
• Technical writing skills, with strong understanding of technical validation and system documentation.
• Knowledge of analytical systems and facility equipment.
• Strong troubleshooting, analytical, and critical thinking skills.
• Effective communication skills, with the ability to collaborate across diverse teams.
• Ability to work independently and collaboratively in a dynamic, demanding environment.
• Ability to manage multiple priorities at once to meet project deadlines.
Requisition ID: 321767 #LI-Hybrid
It is our business imperative to remain a very inclusive workplace.
To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.
The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy
At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.
Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.
Position Summary:
Reporting to the Manager, Facilities, Engineering and Validation, the Quality Engineer role includes aspects of traditional Validation, Facilities, and Operations Engineering disciplines in a GMP environment. You will be involved in supporting and maintaining facilities and equipment ensuring regulatory compliance at all times to ensure the release of VOWST to serve at risk populations. Please note this role is a Hybrid position.
This is an exciting opportunity for anyone who excels at active, and creative problem solving. While this is a GMP environment, it is not your typical experience, our program requiring a unique opportunity to apply GMP principles to an area as yet unregulated by the FDA. Our unique product provides the opportunity to grow within a cutting edge GMP program, setting the benchmark for a new industry.
This role requires not only a strong application of GMP principles, but curiosity and attention to details in a fast-paced environment. You will have the opportunity to be a key contributor to the program as well as grow with the organization as it brings a pioneering product to the market. Due to the unique nature of our product, this is not a cookie cutter assembly of requirements, and requires an excitement and attention to detail to understand the unique biology of our product, and the controls necessary to support it. If you’re excited about the opportunity to learn and apply Engineering skills to a new product, and to grow with our organization, this may be the right place for you.
Key Responsibilities:
• Perform GMP commissioning and qualification activities including the drafting and execution of Installation, Operation, and Performance Qualification and Requalification Protocols.
• Administrate the Validation Management platform and schedule validation events with equipment stakeholders.
• Coordinate and execute calibration and planned maintenance activities on facility and laboratory equipment. Facilitate third-party execution of calibration and planned maintenance activities.
• Work with technical leads and third-party subject matter experts to troubleshoot facility and analytical equipment.
• Operate the Computerized Maintenance Management System (CMMS) for calibration, maintenance, and work order management of equipment and systems.
• Support and lead quality efforts including the drafting and implementation of change controls, deviations, CAPAs, and regulatory filings.
• Draft, revise, and own documents in the quality management system including SOPs, forms, lists, etc.
• Draft and revise engineering documents including specifications, equipment layout diagrams, and PIDs.
• Support and lead interdisciplinary projects to procure, install, commission, and qualify equipment and facility improvements on-time and on-budget.
• Effectively collaborate with cross-functional teams to develop and implement engineering solutions that enhance efficiency, reliability, and compliance of laboratory and Donor facilities.
• The travel requirement for the Engineer II, FEV role is < 20%.
Experience and Education Requirements:
• Bachelor’s degree in a related engineering discipline or equivalent work experience.
• 3+ years of experience in the pharmaceutical industry.
• Strong knowledge of GMP regulations.
• Familiarity with Blue Mountain Regulatory Asset Management or similar platform preferred.
• Familiarity with Kneat Gx or similar platform preferred
• Technical writing skills, with strong understanding of technical validation and system documentation.
• Knowledge of analytical systems and facility equipment.
• Strong troubleshooting, analytical, and critical thinking skills.
• Effective communication skills, with the ability to collaborate across diverse teams.
• Ability to work independently and collaboratively in a dynamic, demanding environment.
• Ability to manage multiple priorities at once to meet project deadlines.
Requisition ID: 321767 #LI-Hybrid
It is our business imperative to remain a very inclusive workplace.
To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.
The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy
Source : Nestle