Validation Engineer

Company: Disability Solutions
Location: Indianapolis
Posted on: November 1, 2024

Job Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionPerforms validation of equipment and systems. Maintains all documentation pertaining to qualification and validation. Develops procedures and/or protocols. Serves as information resource for validation technicians, contractors and vendors.A seasoned professional with wide-ranging experience. Deals with diverse and often times sophisticated issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.The Opportunity:

• Provide expert support in the planning, definition, creation, review and documentation of the validation lifecycle activities through development of validation documents to ensure compliance with FDA regulations, Quality Systems Regulations GxPs, ISPE Good Automated Manufacturing Practices (GAMP) guidelines, and company policies and procedures, safety policies and practices, and other applicable internal controls, policies and procedures for all qualification and validation activities.
• Manage documentation packages for qualification and validation programs as required by project teams to support work with respect to quality and timelines by coordinating guidance from various team functions including domain experts, validation consultants and quality engineering.
• Work with/lead project teams to support the execution of validations by participating in validation execution, supervising compliance of validation documents and reviewing documents for Good Documentation Practices prior to submission for approval.
• Work with project teams to develop validation strategy. May also participate in problem resolution, investigations and deviation development.Who you are:
  • Bachelor's Degree in engineering or closely related scientific/technical field or equivalent work experience.
  • 5 years of related experience.
  • Extensive knowledge of professional concepts and company objectives.Preferred:
    • Engineering degree or a closely related scientific/technical field with 5+ years of experience.
    • Formal training and/or experience in applying Process Risk Assessment, System and Component Classification, FMEA, Control Plans.
    • Expert solid understanding of FDA guidelines for validation, Quality Systems Regulations GxP's (CFR 820, 210, 211 and Part 11), ISPE Good Automated Manufacturing Practices (GAMP) guidelines.
    • In-depth experience with technical or compliance and/or validation/quality assurance documents requirements including validation master plans, user requirement specifications, functional and design specifications, installation and operation qualifications.The expected salary range for this position based on the primary location of Indiana is $82,000 - $152,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .

Keywords: Disability Solutions, Hamilton , Validation Engineer, Engineering , Indianapolis, Ohio