Senior QA Manager
Amgen
Senior Process Engineer, Drug Substance Downstream
Amgen
full-time
Posted on:
Location Type: Office
Location: Holly Springs • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $119,195 - $147,867 per year
Job Level
Senior
About the role
- Design, build, commission, and qualify new equipment and systems needed for drug substance production, focusing on Downstream Process engineering and plant equipment
- Develop domain expertise and system ownership to support process operations
- Support site design, construction, start-up, and operational readiness including equipment design and sizing, architecture and electrical distribution, and P&IDs
- Support factory acceptance testing and site installation, reviewing protocols and resolving punch list items
- Work with capital project team and global engineering to ensure systems are installed and operating safely and meet environmental/health/safety and Amgen global engineering requirements
- Implement and guide commissioning and validation of systems to ensure operational capability aligned with manufacturing requirements and GMP
- Support engineering and performance qualification runs and provide hypercare support as needed
- Perform engineering assessments for plant equipment operations and implement equipment modifications
- Act as responsible system owner for Downstream drug substance process equipment, providing end-to-end operational support
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations
- Work with original equipment manufacturers for breakdown and planned maintenance
- Lead identification and implementation of engineering-based improvements or upgrades, including business case development and translating requirements into equipment/system design
- Develop master maintenance programs, ensure spare parts availability, and coordinate maintenance activities
- Ensure plant readiness and compliance for internal, external agency, and partner audits
- Lead technical root cause analysis and implement corrective/preventive actions
- Lead new product/technology introductions, perform equipment performance risk assessments, identify gaps and own remediation
- Provide rotational on-call support and ensure 24x7 day-to-day reliability of Downstream systems
- Up to 10% domestic/international travel
Requirements
- High school diploma / GED and 10 years of Engineering experience OR Associate’s degree and 8 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Master’s degree and 2 years of Engineering experience OR Doctorate degree
- Bachelor’s degree in Chemical or Mechanical Engineering (preferred)
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment (preferred)
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems
- Direct experience with Downstream purification equipment such as chromatography and viral filtration skids, and UFDF skids
- Experience with supporting equipment such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection
- Experience with Tech Transfer, Process Design, and Commissioning & Qualification
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.)
- Familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Understanding of safety requirements working in a GMP Biopharmaceutical production facility
- Independent, ambitious, organized, able to multi-task in project environments
- Skilled in communication, facilitation, and teamwork
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations
- Ability for domestic/international travel (10%)
- Provide rotational on-call support to ensure 24x7 reliability of Downstream systems
Benefits
- In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
- Competitive benefits to support professional and personal growth and well-being
- Collaborative culture
- Work schedule flexibility as required to support 24/7 operations
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Downstream Process engineeringGMPBiopharmaceutical operationsChromatographyViral filtrationUFDF skidsTech TransferProcess DesignCommissioning & QualificationEngineering assessments
Soft skills
IndependentAmbitiousOrganizedMulti-taskingCommunicationFacilitationTeamworkLeadershipTechnical writingPresentation skills
Certifications
Bachelor’s degree in Chemical EngineeringBachelor’s degree in Mechanical EngineeringMaster’s degreeDoctorate degreecGMPOSHAEPA
