Req ID 56582BR
Business Title Validation Assoc III
Business Global Quality
Sub-Business Medical Products Support
Location of Position Round Lake, IL
Job Description Job Summary: This Validation Associate III position is in the Quality Management organization at the Round Lake Drug Delivery aseptic pharmaceutical manufacturing facility. The incumbent will be expected to lead small to medium scope validation projects to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position encompasses a broad range of engineering disciplines related to equipment, software, process, control system and critical system validation. The incumbent will be responsible for initiating and ensuring proper documentation and training within the scope of the validation and will plan, schedule and lead project assignments with minimal guidance. In addition, the Validation Associate III in this role may also be responsible for evaluation of customer complaints from receipt through resolution and trending.
Duties: With minimal guidance, schedules and leads teams through the planning and execution of small to medium scope validation projects or defined piece of a larger project. This includes preparation of detailed, accurate validation schedules, interfacing with Manufacturing, Process Engineering, Microbiology and Chemistry Laboratories.
Ability to prioritize and execute multiple project tasks.
May be expected to coordinate project work for an engineer and/or technicians on assigned work.
Expected to execute improvements based on technical knowledge and experience to improve the validation process and ensure compliance with appropriate regulatory agency validation requirements, company standards and current industry practices.
Investigate and document analysis of customer complaints consistent with existing Corporate, Divisional Specifications and local procedures. Participate and in some cases lead the efforts to track and trend customer complaints and to proactively resolve potential product issues.
Responsible for organizing data and preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system validation.
Proactively and regularly communicate with the project team to update on validation status with respect to small to medium scope validation projects. Will be required to present on customer complaints to the Drug Delivery management team.
Expected to participate in the development and execution of the change control process, from initiation through closure. Must have the ability to define the requirements for Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification and Validation Maintenance packages.
Responsibilities may also include leading a team of individuals in the execution of failure mode analysis of processes/product, statistical analysis and design of experiments for small to medium scope projects.
* Display a solid understanding of validation practices utilized by other disciplines outside primary area of expertise.
* Ability to lead cross-functional teams, with minimal guidance to resolve small to medium scope validation issues. Must be able to provide solutions that reflect understanding regulatory requirements, business objectives and cost implications.
* Ability to communicate with respect to more complex technical or project management issues, both verbally and in written form. May also be expected to interface with the FDA, Drug Partners and other regulatory agencies with respect to validation projects.
* Must not be allergic to Penicillins or Cephalosporins.
* Minimum of a BA or BS preferably in the Life Sciences/Engineering/Chemistry or other job-related discipline. A minimum of 5+ years related experience in validation within a pharmaceutical, biotech or related industry is preferred. Project Management experience is a plus.
Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at EOE M/F/D/V.