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Sr Engineer, PD Process Validation & Business Holly Springs, NC
Job Location:
Job Location:
Holly Springs, MS - USA
Monthly Salary:
USD 156257 - 156257
Monthly Salary:
Posted:
30 May 2026 (30+ days ago)
Posted:
Application Deadline:
8 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
What you will do
Lets do this. Lets change the this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgens FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility which includes development support and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug addition the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.
Lead the development of Process Validation/Process Performance Qualification strategy for New Products ensuring alignment with regulatory guidelines and industry standards.
Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation technology transfer support and plant start-up
Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities.
Provide cross-functional process monitoring support as needed
Provide guidance for the generation resolution and closure of deviations.
Lead ANC PD business strategy activities to improve network practice develop digital tools and optimize the ANC PD business operations
Ensure safety and compliance of process development activities
Provide process validation floor process support as required
Lead process validation support for regulatory filing inspection and other CMC activities
Lets do this. Lets change the this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgens FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility which includes development support and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug addition the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.
Lead the development of Process Validation/Process Performance Qualification strategy for New Products ensuring alignment with regulatory guidelines and industry standards.
Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation technology transfer support and plant start-up
Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities.
Provide cross-functional process monitoring support as needed
Provide guidance for the generation resolution and closure of deviations.
Lead ANC PD business strategy activities to improve network practice develop digital tools and optimize the ANC PD business operations
Ensure safety and compliance of process development activities
Provide process validation floor process support as required
Lead process validation support for regulatory filing inspection and other CMC activities
Required Experience:
Senior IC
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
