Sr Validation Engineer - Facilities

Job description

·  Job facts

Job Summary

Performs 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 complex 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.

Key Roles & Responsibilities

·  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 deliverables with respect to quality and timelines by coordinating input from various team functions including subject matter experts, validation consultants and quality engineering.
·  Work with/lead project teams to support the execution of validations by participating in validation execution, monitoring 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.

Minimum Qualifications

·  Bachelor's Degree in engineering or closely related scientific/technical discipline 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 discipline with 5+ years of experience.
·  Formal training and/or experience in applying Process Risk Assessment, System and Component Classification, FMEA, Control Plans.
·  Expert 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.
·  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

***Must currently reside within a 50-mile radius of Indianapolis***

Roche is an equal opportunity employer.
Quality, Quality > Quality Validation

·  Who we are

At Roche, 98,000 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.