Overview
On Site
USD 63,600.00 - 118,200.00 per year
Full Time
Skills
Innovation
Management
Technical Drafting
Risk Assessment
Quality Control
Laboratory Equipment
Change Management
Evaluation
Testing
Documentation
Auditing
Mechanical Engineering
Science
Pharmaceutics
Risk Management
GAMP
Mapping
Good Manufacturing Practice
IQ
OQ
PQ
Technical Writing
Communication
Microsoft Excel
Microsoft PowerPoint
Recruiting
Training
Promotions
Accessibility
Computer Networking
Collaboration
HSE
EHS
Heat Transfer
HVAC
Adobe AIR
GDP
GMP
Manufacturing
Optimization
Microsoft Word
Outside Sales
Physics
Software Troubleshooting
Teamwork
Test Equipment
Total Productive Maintenance
Job Details
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:
The salary for this position is expected to range between $63,600 and $118,200 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 benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Minimum Requirements:
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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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 to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$63,600.00 - $118,200.00
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
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 $63,600 and $118,200 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 benefits. In 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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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 to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$63,600.00 - $118,200.00
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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.