Validation Engineer III

Band

Job Description Summary

Job Description

Location: Durham NC

Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham NC.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Responsibilities:

• Oversees URS protocols reports & support records to ensure compliance timely resolution of documentation compliance and quality system issues. Identify coordinate execute and provide oversight of validation activities related to the start-up commissioning qualification validation of a cGMP manufacturing facility (including manufacturing equipment QC lab equipment utilities).

• Performs environmental mapping and other miscellaneous validation activities.

• Evaluates and analyzes validation data for accuracy and adequacy.

• Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment.

• Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries.

• Owns validation Lifecycle documents including Validation Plans Impact Assessments and Validation Reports.

• Reviews and supports Computer Systems Validation efforts for global systems.

• Manages workload to ensure timely approval of validation testing and documentation.

• Assists Quality Assurance Production Quality Control and other departments during inspections or audits.

• Additional duties may include attendance at client meetings preparation of project budgets review of invoices and any other duties as required to control financial and execution related aspects of project.

• Other related duties as assigned.

Requirements:

• BS/MS degree in Chemical Industrial Mechanical or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred)..

• Experience with Biosafety cabinet smoke studies.

• Knowledge of Industry guidelines (ISPE PDA) US and international regulations (FDA ICH ISO EU) for validation of GMP facilities.

• Experience supporting FDA approved commercial products.

• Experience in cGMP environment (IQ OQ PQ) is essential.

• Familiar with current industry best practices including ASTM e2500 to plan efficient/risk-based validation projects.

• Experience with validation tools and processes including environmental mapping and use of Kaye Validator.

• Familiar with GAMP 5 applications and practices.

• Excellent technical writing and verbal communication skills.

• Proficient in Microsoft Word Excel PowerPoint and Project.

• Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution.

Skills:

• Business Continuity.

• Change Control.

• Flexibility.

• General Hse Knowledge.

• Hvac (Heating Ventilation And Air Conditioning).

• Including Gdp.

• Installations (Computer Programs).

• Knowledge Of Capa.

• Knowledge Of Gmp.

• Manufacturing (Production).

• Project Commissioning.

• Project Engineering.

• Project Execution.

• Risk Management.

• Root Cause Analysis (Rca).

Languages:

• English

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $89600 and $166400/year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity -based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired