validation engineer Indianapolis, IN
Job description
Doing now what patients need next. A pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diabetes Care is committed to helping people with diabetes live lives that are as normal and active as possible and helping healthcare professionals manage their patients' condition in an optimal way. The ACCU-CHEK® portfolio-from blood glucose monitoring through information management to insulin delivery - offers innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.
Roche is a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest, which will prepare you for the next level in your career path. We know that people are responsible for our success and we value our employees. Our commitment is to create a work environment where feeling valued, respected, and empowered is a daily experience.
As a Principal Validation Specialist, you will be responsible to...
Accomplish the most complex tasks on a program, platform, and project level team, across ARTs and networks, or as an individual contributor.
Propose, develop, and execute or lead validation plans and activities to ensure compliance and high quality within complex projects and environments.
Coordinate, participate and report in evaluation and decision boards to ensure validation readiness and analyze the validation relevance.
Act as the site point of contact in internal and external audits.
Act as the site point of contact for validation and qualification topics related to external partners.
Maintain the validation program, including co-definition and monitoring of KPIs.
Develop and maintain local validation deliverables and tools.
Act as a local process manager for Process Validation: align with the global process owner on business needs, regulatory expectations, and process optimization techniques needed to establish and maintain compliant and efficient QMS procedures well understood by users.
Act as a coach / consultant with broad subject matter expertise.
Be an active peer coach and mentor to members of the chapter on site to help them grow as quality professionals
Act as a mentor and coach for colleagues in your area of expertise. Coach, encourage, and develop individuals within the organization.
Assist peers in navigating complex and challenging topics in Process Validation to raise the level of performance of the organization, encourage knowledge sharing, and proactively solve difficult problems.
Foster cross-functional collaboration and breaking down silos to achieve the best results for the organization
Navigate and influence within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skill
Enable the organization’s New Ways of Working and support access to the right resources
Act as role model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in the Roche Operating Principles
Work closely with ARTs, similar functions across Roche, and leaders across the business to identify and translate strategic direction into capability needs
Requirements:
Bachelor’s Degree in Engineering (Mechanical, Chemical) or closely related scientific/technical discipline or equivalent work experience.
5 years experience in medical device or related FDA regulated industry.
2 years experience in writing and execution of validation master plans, user requirement specifications, functional and design specifications, installation and operation qualifications.
Broad knowledge of the manufacturing processes and data integrity. Significant experience in validation of equipment, non-product software, clean rooms, and cleaning procedures.
Profound knowledge of validation relevant regulations, standards and associated guidelines pertinent to the industry (e.g. ISO 13485, US 21CFR 820, IVDR / MDR, etc.).
Experience in statistical process control techniques, significant experience in leading projects.
Preferences:
Strong knowledge of continuous process improvement and/or lean / agile processes.
Demonstrated ability to communicate, collaborate, and influence effectively with a variety of internal and external stakeholders in demanding / changing situations to build trust, confidence, and collaboration toward shared objectives.
Project management experience with proven leadership, mentoring, and coaching abilities.
Strong interpersonal, analytical, and problem-solving skills.
Formal training or solid working knowledge of FDA guidelines for validation, Quality Systems Regulations GxP’s (CFR 820, 210, 211 and Part 11), ISPE Good Automated Manufacturing Practices (GAMP) guidelines.
Formal training and/or experience applying Process Risk Assessment, System and Component Classification, FMEA, Control Plans.
At 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.
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 connection with the on-line application process, please email us at [email protected].
