Validation Engineer II

Band

Level 2

Job Description Summary

At Advanced Accelerator Applications a Novartis company we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.

The Validation Engineer will execute and manage process primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expections.

Job Description

Responsibilities :

Supports the development of Validation / Qualification documents including drafting risk assessments qualification protocols deviations and reports. Supports the execution of validation / qualification activities for the site (including manufacturing equipment QC lab equipment utilities).

Reviews evaluates and analyzes validation data for accuracy and adequacy.

Supports the validation execution strategy and timeline for sustained commercial and clinical operations within a validation GMP environment.

Assists with change management validation impact assessments.

Supports the site validation periodic re-evaluation program including periodic reviews and requalifications.

Assists with Validation lifecycle documents.

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

Supports the validation department during inspections or audits.

Other related duties as assigned.

The salary for this position is expected to range between $63600 and $118200 per 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 awards.

US-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.

Minimum Requirements :

BS / MS degree in Chemical Industrial Mechanical or other related engineering / science discipline with a minimum of 2 years of relevant engineering experience in the pharmaceutical or Biopharmaceutical industry.

Familiarity with good engineering practices validation tools and processes risk management GAMP 5 applications and practices (including environmental mapping and use of Thermal Mapping equipment is preferred).

Experience in cGMP environment (IQ OQ PQ).

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

Strong technical writing and verbal communication skills.

Proficient in Microsoft Word Excel PowerPoint and Project.

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

$63600.00 - $118200.00

Skills Desired

Architectural Engineering Business Networking Cooperation Efficiency Employee Welfare General Hse Knowledge Heat Transfer HVAC (Heating Ventilation And Air Conditioning) Including Gdp Job Description Knowledge Of Gmp Manufacturing Production Mathematical Optimization Microsoft Word Outside Sales Physics Qualification Software Troubleshooting Team Work Test Equipment Total Productive Maintenance

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 63600 - 118200