Senior Validation Engineer

2 weeks ago

Fall River, United States Millstone Medical Full time

***Relocation assistance and visa sponsorship is not available for this position***


Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work


Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.


Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.


What's in it for you?


A company committed to quality, growth, career pathing.


At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.


Total Rewards Benefits Program:

  • Medical - Starting on the 1st day of employment
  • Dental - Starting on the 1st day of employment
  • Vision - Starting on the 1st day of employment
  • Supplemental Benefits - Life, Disability, Critical Illness
  • Paid Time Off
  • Tuition Reimbursement
  • Career Pathing
  • 401(k) with match

To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.


Job Summary:

The Validation Engineer is responsible for executing and documenting equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes. This role involves creating manufacturing work instructions, interfacing with customers on technical issues, and supporting project timelines. The Validation Engineer will also actively participate in cross-functional teams to identify root causes and implement corrective actions for issues encountered during investigations. Depending on the level of the position, the Validation Engineer may lead projects of moderate scope and duration or independently perform detailed engineering tasks.


Key Responsibilities:

  • Equipment and Process Validation:
  • Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various manufacturing equipment and end-of-line processes.
  • Ensure that all validations are conducted in accordance with Good Manufacturing Practices (GMPs) and meet customer and regulatory requirements.
  • Manufacturing Work Instructions:
  • Develop, maintain, and update manufacturing work instructions to ensure that validated processes are accurately followed in production.
  • Collaborate with operations and quality teams to ensure work instructions are clear, concise, and effective.
  • Customer Interface:
  • Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
  • Communicate effectively with customers to manage expectations and ensure alignment on validation activities.
  • Cross-Functional Team Participation:
  • Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions.
  • Collaborate with Quality, Manufacturing, and R&D teams to support continuous improvement initiatives and resolve validation-related challenges.
  • Operational Support:
  • Provide ongoing support to operations by troubleshooting issues related to validated processes and equipment.
  • Communicate effectively with Program Managers to ensure alignment on project goals and timelines.
  • Training and Development:
  • Train operations personnel on validated processes, work instructions, and equipment operation to ensure compliance with established procedures.
  • Mentor junior engineers or technicians as needed.
  • Project Management (Depending on Position Level):
  • Lead projects of moderate scope and duration, including defining project scope, schedule, team roles, and responsibilities.
  • Independently perform and coordinate detailed phases of engineering work, ensuring project tasks are completed on time and within budget.


Skills Required:


  • Education:
  • Bachelor’s degree in Engineering is required.
  • Experience:
  • Depending on the level of the position, 4-8 years of relevant experience in validation engineering, preferably in a manufacturing environment.
  • Experience with IQ, OQ, and PQ protocols is required.
  • Knowledge of Good Manufacturing Practices (GMPs) is essential.
  • Technical Writing:
  • Strong technical writing skills are required to develop and document client process validations.
  • Communication and Problem-Solving:
  • Excellent communication skills, both verbal and written, to interface effectively with customers, cross-functional teams, and operations personnel.
  • Exceptional attention to detail, analytical abilities, and problem-solving skills.
  • Independence and Leadership (Depending on Position Level):
  • Ability to work independently and initiate/manage communications with customers.
  • Ability to negotiate with clients on project timelines, processes, and validation activities.
  • Experience in developing systems to improve standard processes is preferred.


ADDITIONAL INFORMATION:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

  • Senior Validation Engineer

    2 weeks ago

    Fall River, United States Millstone Medical Full time

    ***Relocation assistance and visa sponsorship is not available for this position***Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!Millstone is a fast growing, fast paced medical service provider for the top Orthopedic...

  • Senior Validation Engineer

    2 months ago

    Fall River, United States Millstone Medical Full time

    ***Relocation assistance and visa sponsorship is not available for this position***Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!Millstone is a fast growing, fast paced medical service provider for the top Orthopedic...

  • Senior Capital Projects Engineer

    2 weeks ago

    Fall River, Massachusetts, United States Westlake Full time

    Senior Capital Projects EngineerAbout the Role: Are you ready to advance your career as a Senior Engineer in Capital Projects? This position is vital for the effective execution of capital initiatives that enhance operational efficiency, promote growth, facilitate product innovation, and uphold safety standards. Collaborating closely with the Capital...

  • Validation Engineer

    2 months ago

    Haw River, United States Sotera Health Services, LLC Full time

    Job Description Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, the Validation Engineer acts as the facility technical representative responsible for ensuring the requirements for ISO are met and maintained for the facility and its customers. Validation Engineer will provide management with information and data on all key...

  • Senior Project Engineer

    1 week ago

    Fall River, Massachusetts, United States Westlake Full time

    About the OpportunityWe are seeking a highly skilled Senior Project Engineer to join our Capital Projects team at Westlake. As a key member of our organization, you will play a crucial role in ensuring the successful execution of capital projects and initiatives that drive operational efficiency, growth, product development, and safety measures.Key...

  • Senior Project Engineer

    1 week ago

    Fall River, Massachusetts, United States Westlake Full time

    About the OpportunityWe are seeking a highly skilled Senior Project Engineer to join our Capital Projects team at Westlake. As a key member of our organization, you will play a crucial role in ensuring the successful execution of capital projects and initiatives that drive operational efficiency, growth, product development, and safety measures.Key...

  • Certified Nursing Assistant

    12 hours ago

    Fall River, Massachusetts, United States Benchmark Senior Living Full time

    About UsBenchmark Senior Living is a leading provider of senior living communities, dedicated to delivering exceptional care and services to our residents. Our mission is to create a culture of compassion, respect, and excellence in every aspect of our operations.Job SummaryWe are seeking a highly skilled and compassionate Certified Nursing Assistant (CNA)...

  • Senior Systems Engineer

    2 months ago

    Fall River, United States SSTAR Full time

    Job DescriptionJob DescriptionAbout UsWe're more than just quality treatment for substance use disorders. We're a total health community. At SSTAR, our mission is healing the community, one person at a time. We will provide a personal level of healthcare and addiction treatment that addresses the mental, physical, and spiritual well-being of everyone...

  • Senior Systems Engineer

    4 days ago

    Fall River, United States SSTAR Full time

    Job Description:Considering making an application for this job Check all the details in this job description, and then click on Apply.Shift: First ShiftAbout UsWe’re more than just quality treatment for substance use disorders. We’re a total health community. At SSTAR, our mission is healing the community, one person at a time. We will provide a personal...

  • Senior Installation Specialist

    1 week ago

    Fall River, Massachusetts, United States Path Engineering Full time

    Position OverviewAs a Senior Installation Specialist at Path Engineering, your primary responsibilities will include:Installation Duties: You will be tasked with the installation of mounting brackets, refrigerants, indoor air handlers, and securing heat pump systems to their respective mounting structures.Technical Skills: Demonstrate proficient copper...

  • Mechatronics Engineer

    3 days ago

    Fall River, Massachusetts, United States Velocity Enterprises Full time

    Job OverviewAs a Mechatronics Engineer at Velocity Enterprises, you will play a crucial role in shaping the future of mobility while minimizing environmental impact.Key ResponsibilitiesDevelop and implement technical solutions to ensure efficient and sustainable mobility systems.Collaborate with cross-functional teams to design and optimize mechatronic...

  • Engineer (Verification Validation & Accreditation)-Junior

    2 months ago

    Patuxent River, United States AMEWAS American Electronic Warfare Associates, Inc. Full time

    AMEWAS is celebrating over 40 years of excellence in providing quality products, services and solutions to the Department of Defense (DoD), specializing in the scientific, engineering, and testing of the full spectrum of weapons development. We are headquartered in California, Maryland and operate satellite offices in Orlando, Florida and San Diego,...

  • Engineer (Verification Validation & Accreditation)-Junior

    3 months ago

    Patuxent River, United States Amewas Full time

    AMEWAS is celebrating over 40 years of excellence in providing quality products, services and solutions to the Department of Defense (DoD), specializing in the scientific, engineering, and testing of the full spectrum of weapons development. We are headquartered in California, Maryland and operate satellite offices in Orlando, Florida and San Diego,...

  • Engineer (Verification Validation & Accreditation)-Junior

    2 months ago

    Patuxent River, United States AMEWAS American Electronic Warfare Associates, Inc. Full time

    AMEWAS is celebrating over 40 years of excellence in providing quality products, services and solutions to the Department of Defense (DoD), specializing in the scientific, engineering, and testing of the full spectrum of weapons development. We are headquartered in California, Maryland and operate satellite offices in Orlando, Florida and San Diego,...

  • Mining Engineer Internship Opportunity

    3 days ago

    Fall River, Massachusetts, United States Heidelberg Materials US, Inc. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Mining Engineer Intern to join our team at Heidelberg Materials US, Inc. in a dynamic and challenging internship program.Key ResponsibilitiesParticipate in a comprehensive program in mining planning and design to gain hands-on experience in the field.Collaborate with experienced professionals...

  • Manufacturing Engineer

    3 days ago

    Fall River, Massachusetts, United States Millstone Medical Full time

    Job Summary:Millstone Medical is seeking a highly skilled Manufacturing Engineer to join our team. As a Manufacturing Engineer, you will be responsible for developing and implementing mistake-proof processes, equipment, and tooling used to execute on critical cleaning and sterile packaging of orthopedic medical devices.Responsibilities:Provide technical...

  • CNA - Certified Nursing Assistant

    6 days ago

    Fall River, United States Benchmark Senior Living Full time

    Blenheim-Newport believes in the power of the human connection to transform lives. Our associates are part of setting a new standard in senior living by connecting residents and families to what matters most to them. At Benchmark our associates are "called to care." We hire for heart and train for skill-continually pursuing excellence and providing the best...

  • Performance Marketing Manager

    1 month ago

    Fall River, United States D2G Group LLC Full time

    Job DescriptionJob DescriptionJoin Our Team as a Senior Manager, Performance Marketing!Are you ready to lead the charge in driving customer acquisition and revenue growth? Do you thrive in a dynamic environment where creativity and data-driven insights come together to create impactful marketing strategies? If so, we want you on our team! About the Role:As...

  • Senior Manager, Growth Marketing

    2 weeks ago

    Fall River, United States D2G Group LLC Full time

    Job DescriptionJob DescriptionJoin Our Team as a Senior Manager, Growth Marketing!Are you ready to lead the charge in driving customer acquisition and revenue growth? Do you thrive in a dynamic environment where creativity and data-driven insights come together to create impactful marketing strategies? If so, we want you on our team! About the Role:As our...

  • Paid Media, Senior Manager

    1 week ago

    Fall River, United States D2G Group LLC Full time

    Job DescriptionJob DescriptionJoin Our Team as a Senior Manager, Growth Marketing!Are you ready to lead the charge in driving customer acquisition and revenue growth? Do you thrive in a dynamic environment where creativity and data-driven insights come together to create impactful marketing strategies? If so, we want you on our team! About the Role:As our...