Sr Validation Specialist (Process Validation)
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Sr. Validation Specialist / Engineer
Focus: Process Validation
The Senior Validation Specialist is responsible for planning, scheduling, execution and leading validation project assignments. Validation assignments include design, development, validation, qualification, and implementation of new and existing facilities, utilities, products, processes, equipment, and instrumentation systems. Leads cross-functional project teams in the development and implementation of the validation plan and protocols.
Responsibilities include:
• Schedule, plan, manage and execute installation, operation and performance qualifications
of manufacturing, packaging, laboratory, utility systems and equipment in accordance with
current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change
control. Authors related plans, protocols and summary reports.
• Schedule, plan, manage and execute studies for cleaning validation, product hold times, and
any other study identified. Authors related plans, protocols and summary reports.
• Schedule, plan, manage and execute process validation studies. Authors related plans,
protocols and summary reports.
• Reviews and approves validation project documentation.
• Coordinates and interfaces with Process Unit Heads, Engineering and Quality Assurance
groups to assure successful project execution.
• Leads and coordinates cross-functional project teams for validation projects.
• Prioritizes, manages and executes multiple projects utilizing Project Management
methodology.
• Oversees external validation resources that may be used in the validation project.
• Support development of best demonstrated validation practices within the validation
department, based on current industry practices and guidelines.
• Author assigned Standard Operating Procedures (SOPs) to ensure compliance with Company
policies and federal regulations.
• Support regulatory submissions and regulatory agency inspections as required.
• Champions continuous improvement within the Validation department.
Education and Experience:
• Bachelor’s or higher degree in Engineering or the life sciences or other related field
• Minimum of 8 years of validation experience in a highly regulated environment:
pharmaceutical, biotechnology or related industry, including significant exposure to the
regulatory requirements affecting validation.
• Minimum of 3 years experience in the validation and qualification of
manufacturing/packaging equipment qualification, computer systems validation, utility
systems qualification or process validation.
• Project Management experience required.
• Lean Manufacturing or Six Sigma certification preferred.
Skills and Competencies:
• Possess in-depth knowledge of GMP and regulations related to commissioning and
qualification of manufacturing, packaging and laboratory equipment, utility systems,
validation of computerized systems, and cleaning and process validation.
• Strong knowledge and understanding of applicable regulatory and quality requirements in an
FDA-regulated environment and knowledge of 21 CFR Part 11.
• Ability to manage, organize and troubleshoot complex technical problems. Strong problem-
solving skills.
• Strong oral and written communication skills with excellent technical writing abilities.
• Strong attention to detail and organizational skills.
• Proficiency in the use of personal computers and software programs including Microsoft
Word, Excel and PowerPoint.
• Results-oriented with ability to adapt to changing priorities.
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