Summary :
In this vital role, you will be part of the Drug Substance Technology and Engineering group within the Process Development organization.
One of the primary responsibilities will be providing technical leadership for Single Use components and assemblies. In this role, you will also introduce new technologies to the network and will be supporting investigations of clients’ global manufacturing.
Responsibilities :
Support of Single Use network in terms of design and investigation
Use process engineering and equipment design experience, to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges.
Analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.
Provide leadership on capital projects.
Provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs.
Support and / or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.
Support the client’s single use global network as a drug substance domain expert.
Top 3 Must Have Skill Sets :
Background in Single Use Technologies
Background in Process Engineering
Project management skills
Validation experience
Basic Qualifications :
High school diploma / GED and 12 years of Engineering or Operations experience OR Associate’s degree and 10 years of Engineering or Operations experience OR Bachelor’s degree and 5 years of Engineering or Operations experience OR Master’s degree and 3 years of Engineering or Operations experience OR Doctorate degree
Preferred Qualifications :
Master’s degree and 6+ years of directly related experience, or PhD with 2+ years of directly related experience
Strong understanding of GMP equipment design and biologics manufacturing requirements
Detailed knowledge of multiple unit operations
Experience leading root cause analyses and solving GMP manufacturing issues
Ability to apply sophisticated problem solving skills within defined constraints
Experience providing process engineering support of pilot / clinical / commercial processes
Compensation :
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries :
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Senior GNC Engineer
Senior Guidance, Navigation and Control Engineer. They are seeking a Senior GNC Engineer to join their innovative team and lead the development of our client's guidance, navigation, and control system, shaping the future of space technology. Qualifications in aerospace engineering or a related field...
Senior DevOps Engineer
We're looking for an experienced DevOps Engineer to join a world-class software team in Santa Clara (Hybrid). You'll collaborate closely with software engineering teams to ensure the consistent delivery of high-quality software to our customers. Collaborate with software engineering and product team...
Senior Flight Software Engineer
As a Senior Flight Software Engineer, you'll design and implement embedded software solutions across the full flight software development lifecycle, reporting directly to the CTO / Co-Founder. Senior Flight Software Engineer Responsibilities. Senior Flight Software Engineer Requirements. If you have...
Senior Machine Learning Engineer
Revival Talent, in partnership with a leading innovator in health tech, is seeking a Senior Machine Learning Engineer for a remote (hybrid) role. Senior Machine Learning Engineer, preferably in healthcare/medical software. If you're a seasoned Senior Machine Learning Engineer local to the San Franci...
Senior Infrastructure Engineer
Degree and 8 years of experience in systems engineering, including systems programmers, scripting, and troubleshooting; or a high school diploma or GED; and 12 years of experience in systems engineering, including systems programmers, scripting, and troubleshooting. Title: Infrastructure Engineer/Po...
Senior Network Engineer
We are seeking a Senior Network Engineer!. Akkodis is partnering with a global technology company specializing in end-to-end solutions for immersive experiences, providing physical design, engineering, manufacturing, software, display engines, and content for entertainment, science, education, and a...
Senior Hardware Engineer - Product Engineering
We are looking for a Senior Hardware Engineer to join our Product Engineering team. Participate in both Engineering and Operations environments - accomplishment in both domains is desired. You will work with a collaborative team of system, electrical, mechanical, software, manufacturing, production ...
Senior CPU Design Engineer
You will work closely with architects, design engineers, verification engineers, and physical design engineers teams to accomplish your tasks. We are looking for a Senior CPU Design Engineer!. BS or MS in electrical engineering or computer engineering (or equivalent experience). NVIDIA is seeking be...
Senior Identity Access Management Security Engineer
The Identity & Access Management Senior Security Engineer is responsible for acting as resource, leader, and peer coach with other engineers in the development, testing, implementation, and integration of Identity and Access Management systems and solutions. Ensures senior management and staff are i...
Senior Cybersecurity Engineer
Bachelor's degree in Computer Engineering, Computer Science, Information Systems, Cybersecurity, or equivalent education/experience required. ...