The CQV Engineer has responsibility for executing and managing equipment, facility, utility, process, primary packaging 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 expectations. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.
• Support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Support site lead in maintaining the process control strategy.
• Support drafting of CSV activities for lab and manufacturing equipment.
• Supporting on going qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification, requalification.
• Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.
• Prepare and review appropriate GxP documentation including change requests.
• Identify improvement options of current processes, propose business cases
The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Commitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.Role Requirements
• Bachelor’s degree in biology, chemistry, engineering, or related. Master’s degree is preferred.
• Minimum of 3+ years’ experience in executing equipment commissioning, qualification, process validation.
• 1+ years’ experience leading validation projects is preferred.
• Expert in reviewing and writing technical reports.
• Fundamental understanding of standard pharmaceutical analytical testing.
• Operations Management and Execution Project Management Process and Cleaning Validation Manufacturing Process/Product Expertise Quality Change Control Data analytics collaborating across boundaries.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and 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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
br{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Experis is a part of Manpower Group family of brands. ManpowerGroup has partnered with a...
Apply For This JobAbout the roleSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> What You Will Do: NEP’s Network Engineer will lead the daily activities of our datacenter...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Are you looking for a great new career and to take your customer service experience...
Apply For This JobAbout the department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide....
Apply For This JobJob DescriptionAt Novartis, you play a key role in shaping the employee experience of all 14,000 US associates, supporting them...
Apply For This Job