Process Engineer - Solution Preparation
Amgen
18 days ago
On-site
Holly Springs, NC
Operations
Process Engineer - Solution Preparation
What You Will Do
- Partner with corporate engineering to support design, build, commissioning, and qualification of new equipment/systems for drug substance production, focusing on Solution Preparation process equipment.
- Participate in FATs/SATs and support installation, commissioning, and qualification of Solution Preparation equipment in alignment with GMP.
- Ensure systems are installed and operating safely and comply with EHS rules/regulations.
- Support water runs, engineering runs, and process qualification activities.
- Work with manufacturing, engineering, and maintenance teams to support procedures and apply lessons learned to new plant.
Site Operations
- Provide system ownership/support for Solution Preparation biopharmaceutical process equipment (e.g., Single-use Mixers, Downflow Booths, Scales, Stainless Prep/Hold Vessels, CIP Skids).
- Identify and implement engineering improvements/upgrades to increase equipment/unit operation reliability (including business cases, design/spec translation, and support construction/startup/validation).
- Execute the master maintenance program (MMP) and coordinate maintenance with OEMs.
- Troubleshoot and resolve process/system issues; support root cause analysis and corrective/preventive actions.
- Support new product/technology introductions (fit assessments, equipment modifications, engineering runs).
- Ensure 24x7 day-to-day reliability; participate in rotational on-call support.
Basic Qualifications
- High School/GED + 10 years Engineering OR Associate’s + 8 OR Bachelor’s + 4 OR Master’s + 2 OR Doctorate.
Preferred Qualifications / Skills
- BS in Chemical or Mechanical Engineering.
- 6+ years relevant; 5+ years in biopharmaceutical operations/manufacturing.
- Direct experience with Solution Preparation and CIP/SIP skids in biopharmaceutical facilities.
- Data-driven problem solving (analytics, RCA, SPC, Six Sigma, predictive maintenance).
- Regulated environment experience (cGMP/OSHA/EPA) and familiarity with GMP systems (change control, CAPA, qualification/validation).
- Capital project experience in GMP biopharmaceutical environments (procurement, construction, startup, validation).
- Safety knowledge; independent, organized, able to multitask; strong communication/teamwork.
Application Instructions
- Apply at careers.amgen.com.
What You Will Do
- Partner with corporate engineering to support design, build, commissioning, and qualification of new equipment/systems for drug substance production, focusing on Solution Preparation process equipment.
- Participate in FATs/SATs and support installation, commissioning, and qualification of Solution Preparation equipment in alignment with GMP.
- Ensure systems are installed and operating safely and comply with EHS rules/regulations.
- Support water runs, engineering runs, and process qualification activities.
- Work with manufacturing, engineering, and maintenance teams to support procedures and apply lessons learned to new plant.
Site Operations
- Provide system ownership/support for Solution Preparation biopharmaceutical process equipment (e.g., Single-use Mixers, Downflow Booths, Scales, Stainless Prep/Hold Vessels, CIP Skids).
- Identify and implement engineering improvements/upgrades to increase equipment/unit operation reliability (including business cases, design/spec translation, and support construction/startup/validation).
- Execute the master maintenance program (MMP) and coordinate maintenance with OEMs.
- Troubleshoot and resolve process/system issues; support root cause analysis and corrective/preventive actions.
- Support new product/technology introductions (fit assessments, equipment modifications, engineering runs).
- Ensure 24x7 day-to-day reliability; participate in rotational on-call support.
Basic Qualifications
- High School/GED + 10 years Engineering OR Associate’s + 8 OR Bachelor’s + 4 OR Master’s + 2 OR Doctorate.
Preferred Qualifications / Skills
- BS in Chemical or Mechanical Engineering.
- 6+ years relevant; 5+ years in biopharmaceutical operations/manufacturing.
- Direct experience with Solution Preparation and CIP/SIP skids in biopharmaceutical facilities.
- Data-driven problem solving (analytics, RCA, SPC, Six Sigma, predictive maintenance).
- Regulated environment experience (cGMP/OSHA/EPA) and familiarity with GMP systems (change control, CAPA, qualification/validation).
- Capital project experience in GMP biopharmaceutical environments (procurement, construction, startup, validation).
- Safety knowledge; independent, organized, able to multitask; strong communication/teamwork.
Application Instructions
- Apply at careers.amgen.com.