V
Sr Engineer, PD Process Validation & Business - Holly Springs, NC
Accepting applicationsVetJobs · Holly Springs, NC
Full-Time Mid_senior ATEaiarmasicate
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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
Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s 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 substances. In 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
Auto req ID
472925BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Basic Qualifications
High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
Associate’s degree and 8 years of biologics process development, process engineering, or process validation experience OR
Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience OR
Master’s degree and 2 years of biologics process development, process engineering, or process validation experience OR
Doctorate degree
Preferred Qualifications
5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
Independently motivated with successful ability to multi-task and work in teams
Demonstrated leadership skills and decision-making experience
Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Salary Range
115,494.60USD -156,257.40 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Show more Show less
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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
Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s 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 substances. In 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
Auto req ID
472925BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Basic Qualifications
High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
Associate’s degree and 8 years of biologics process development, process engineering, or process validation experience OR
Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience OR
Master’s degree and 2 years of biologics process development, process engineering, or process validation experience OR
Doctorate degree
Preferred Qualifications
5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
Independently motivated with successful ability to multi-task and work in teams
Demonstrated leadership skills and decision-making experience
Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Salary Range
115,494.60USD -156,257.40 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Show more Show less