Associate Principal Engineer
Apply NowCompany: AstraZeneca
Location: Durham, NC 27713
Description:
Are you ready to lead and inspire a team dedicated to ensuring the highest standards of validation within our site? As the Site Validation Team Lead, you will oversee the validation processes, ensuring compliance with both site and global standards. This role involves managing the qualification and validation of equipment, utilities, facilities, and computer systems, while providing coaching and guidance to your team. Join us in driving positive change and action!
Accountabilities
Essential Skills/Experience
- Bachelor's degree required, preferably in Science or Engineering
- 8+ years of relevant experience in the pharmaceutical industry
- Experience leading cross-functional teams, overseeing projects related to validation work
- GMP site validation experience including Site Qualification and Validation, qualification of equipment, utilities, facilities, and computer systems
- Demonstrated applied knowledge and understanding of validation and qualification principles
Desirable Skills/Experience
- Master's degree is highly desirable
- Six Sigma green belt or equivalent experience is preferred
- Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable
At AstraZeneca, we are at the forefront of pioneering new approaches and processes across our sites. We empower our teams to foster a Lean mindset and sustainable practices, ensuring every change we make delivers better outcomes for our patients. Our environment is one of constant evolution where every voice is heard, building trust and respect within our teams. We thrive on adaptability, drawing on diverse expertise to overcome obstacles together. Here, you will find opportunities for growth beyond your role in a supportive team that values initiative and ambition.
Ready to take on this exciting challenge? Apply now to join us in making a difference!
Date Posted
14-Apr-2025
Closing Date
21-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Accountabilities
- Responsible for site Qualification and Validation Plans that include validation and qualification of equipment, utilities, facilities, and computer systems
- Develop, implement, integrate, and sustain validation systems to enhance compliance in accordance with site and global standards
- Create and implement changes in the qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base
- Collaborate with system owners such as operations and labs to sustain or improve validated systems
- Manage and control validation documents
- Serve as a subject matter expert for equipment, process, computer system, and validation systems for site regulatory inspections
- Develop and maintain effective relationships with internal and external customers, regulators, and other stakeholders
- Update, review, and approve area procedures to ensure compliance with Good Manufacturing Practices
- Solve qualification and validation issues using critical analysis skills; develop sound, reasoned solutions and recommendations
- Evaluate new projects or existing equipment modifications in terms of qualification and calibration needs regarding the quality impact
- Manage the qualification activities associated with all Quality Investigations and Change Controls
- Make effective financial and operational decisions to positively impact both short and long-term objectives
- Manage validation resources to ensure site business needs are met
- Work closely with the IT teams responsible for cybersecurity, especially for projects involving our validated systems
Essential Skills/Experience
- Bachelor's degree required, preferably in Science or Engineering
- 8+ years of relevant experience in the pharmaceutical industry
- Experience leading cross-functional teams, overseeing projects related to validation work
- GMP site validation experience including Site Qualification and Validation, qualification of equipment, utilities, facilities, and computer systems
- Demonstrated applied knowledge and understanding of validation and qualification principles
Desirable Skills/Experience
- Master's degree is highly desirable
- Six Sigma green belt or equivalent experience is preferred
- Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable
At AstraZeneca, we are at the forefront of pioneering new approaches and processes across our sites. We empower our teams to foster a Lean mindset and sustainable practices, ensuring every change we make delivers better outcomes for our patients. Our environment is one of constant evolution where every voice is heard, building trust and respect within our teams. We thrive on adaptability, drawing on diverse expertise to overcome obstacles together. Here, you will find opportunities for growth beyond your role in a supportive team that values initiative and ambition.
Ready to take on this exciting challenge? Apply now to join us in making a difference!
Date Posted
14-Apr-2025
Closing Date
21-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.