Engineer I - 2º Shift
Amgen
2 hours ago
On-site
Holly Springs, NC
Operations
ENGINEER I – DOWNSTREAM OR UPSTREAM – 2º Shift (2nd Shift: 3pm to 11pm)
Responsibilities
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including business case development, design requirements, and support for construction, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partner groups to ensure reliable plant operations.
- Develop equipment maintenance programs, ensure spare-part availability, and coordinate maintenance activities.
- Ensure systems are installed and operate safely in alignment with environmental health/safety rules and regulations.
- Ensure commissioning and qualification align with GMP requirements and interact with regulatory inspectors.
- Identify performance risks and implement risk reduction strategies.
- Provide problem-solving support to reduce production downtime, including technical root cause analysis and corrective/preventive action.
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
- Provide rotational on-call support; ensure 24x7 reliability of upstream and downstream systems.
- Ensure plant readiness and quality/regulatory compliance for internal, external agency, and partner audits.
Basic Qualifications
- High school diploma/GED and 8 years of Engineering/Maintenance experience OR Associate’s degree and 6 years OR Bachelor’s degree and 2 years OR Master’s degree.
Preferred Qualifications
- Bachelor’s degree in Chemical or Mechanical engineering.
- GMP biopharmaceutical production facility equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, tangential flow filtration; autoclaves, CIP systems, washers, clean steam, water for injection).
- Experience with equipment/facility control systems (operation, logic, troubleshooting).
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and GMP quality systems (change control, non-conformances, CAPA, qualifications/validation).
- Leadership, technical writing, communication/presentation; ability to work with minimum direction.
- Analytical/problem-solving, facilitation, and collaboration in cross-functional teams.
- Experience with GMP capital projects (procurement, construction, startup, validation) and safety requirements.
- Ability to support 24/7 operations with occasional after-hours engineering coverage.
Benefits (if applicable)
- Retirement and Savings Plan with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
Responsibilities
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including business case development, design requirements, and support for construction, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partner groups to ensure reliable plant operations.
- Develop equipment maintenance programs, ensure spare-part availability, and coordinate maintenance activities.
- Ensure systems are installed and operate safely in alignment with environmental health/safety rules and regulations.
- Ensure commissioning and qualification align with GMP requirements and interact with regulatory inspectors.
- Identify performance risks and implement risk reduction strategies.
- Provide problem-solving support to reduce production downtime, including technical root cause analysis and corrective/preventive action.
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
- Provide rotational on-call support; ensure 24x7 reliability of upstream and downstream systems.
- Ensure plant readiness and quality/regulatory compliance for internal, external agency, and partner audits.
Basic Qualifications
- High school diploma/GED and 8 years of Engineering/Maintenance experience OR Associate’s degree and 6 years OR Bachelor’s degree and 2 years OR Master’s degree.
Preferred Qualifications
- Bachelor’s degree in Chemical or Mechanical engineering.
- GMP biopharmaceutical production facility equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, tangential flow filtration; autoclaves, CIP systems, washers, clean steam, water for injection).
- Experience with equipment/facility control systems (operation, logic, troubleshooting).
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and GMP quality systems (change control, non-conformances, CAPA, qualifications/validation).
- Leadership, technical writing, communication/presentation; ability to work with minimum direction.
- Analytical/problem-solving, facilitation, and collaboration in cross-functional teams.
- Experience with GMP capital projects (procurement, construction, startup, validation) and safety requirements.
- Ability to support 24/7 operations with occasional after-hours engineering coverage.
Benefits (if applicable)
- Retirement and Savings Plan with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.