Validation Steward job in Huntington
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||West Virginia (WV)|
The Validation Steward will be responsible for leading the validation program and validation strategy. The position reports into the Validation Lead. This role will be a key interface between Validation, Manufacturing, Quality and Engineering and will drive the validation efforts to maintain the site in a compliant state. Validation Steward will also support the Risk Management and Change management activities at Alcon.|
Understand the validation operating standards and support development of validation life cycle documents including test plans based on functional and technical specifications/standards. Manage the need of development of validation content (protocol and report). Author/Co-Author/Review complex validation protocols. Support the development of validation execution strategy with project teams for Process, Computer Systems, Equipment, Test Methods and Cleaning Validation. Responsible for supporting both mechanical and chemical processes as well as metrology systems supporting process controls. Development of acceptance criteria and sampling plans for process control and process monitoring. Capability to venture and lead validation help desk forum to ensure that the validations are following procedure consistently with medical device and Alcon standards (e.g. 21 CFR 820). Define and oversee process validation activities including validation assessments for change control. Demonstrate the working knowledge of OneCSV and 21 CFR Part 11. Ensure the Validation Package is consistent with Current Industry standard for OneCSV. Accountable for Validation Master List (VML) is updated, specific to assigned area. Leads the trending of Validation Matrix (per corporate and local standards) and take actions. Accountable to be current on standards, training and updating procedures. Support Validation Lead to write and maintain the site VMP per the identified schedule, or as major events occur at the site (new product transfer, major equipment change, etc.). Support Validation lead to establish and maintain the manufacturing/process risk management program. Collaborate with Engineering and Quality and support the execution of projects, investigations, and/or troubleshooting. Support cross-functional root cause analysis and problem solving on escalated technical product / process issues (e.g., recurring deviations, quality-investigations, CAPA-studies). Collaborate with MS&T, Manufacturing and QA in order to streamline the process while still maintaining compliance and process control.Bachelors or (Preferred)Masters Degree in Scientific Discipline (Chemical Engineering) or 13 Years of experience in validation and manufacturing science. Excellent English and local site language. Preferred: Experience in the regulated industry with manufacturing processes & related equipment, validation or technical process development. Expert in reviewing and writing technical reports. Project management experience Ability to multitask, and manage parallel path project with resources constraint while maintaining timeline. Established experience with: Product development, Design Controls, Design Review • Pre-Validation activities (e.g. Process Development & Characterization) and linkage to Process Validation and Process Control. • Validation (Process/Equipment/Computerized Systems/Cleaning) • Test Method development and validation • Applied Statistics (Design of Experiment (DOE)) • Able to solve very complex problems that require creativity • Proficient at influencing subordinates, peers, and senior management • Self-directed Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authority.