Engineer I - Multiple Shifts
Amgen
4 hours ago
On-site
Holly Springs, NC
Operations
ENGINEER I – DOWNSTREAM OR UPSTREAM – MULTIPLE SHIFTS
Responsibilities include:
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including business cases, design requirements, and translation into equipment/system design, specification, construction support, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partners to ensure reliable plant operations.
- Develop equipment maintenance programs, ensure spare parts availability, and coordinate maintenance activities.
- Ensure systems are installed/operating safely and aligned with environmental health/safety practices, rules, and regulations.
- Ensure commissioning and qualification align with GMP requirements; 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 and ensure 24x7 day-to-day reliability of upstream and downstream systems.
- Lead technical problem-solving to reduce downtime for families of systems.
- Support plant readiness, quality, and regulatory compliance for internal/external/partner audits.
Basic qualifications:
- High school diploma/GED + 8 years Engineering/Maintenance experience OR
- Associate’s degree + 6 years Engineering/Maintenance experience OR
- Bachelor’s degree + 2 years Engineering/Maintenance experience OR
- Master’s degree
Preferred qualifications (skills/experience):
- BS in Chemical or Mechanical engineering.
- GMP biopharmaceutical production equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, TFF) plus related systems (autoclaves, CIP, washers, clean steam, water for injection).
- Experience with equipment/facility control systems operation, logic, and troubleshooting.
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems (change control, non-conformances, CAPA, qualifications/validation).
- Leadership, technical writing, communication/presentation; ability to work with minimum direction.
- Interpersonal/facilitation skills and collaborative, cross-functional teamwork.
- Analytical ability to evaluate sophisticated problems using multiple information sources.
- Engineering principles applied to system modifications, new process introductions, and capital projects.
- Capital project execution knowledge in GMP facilities (procurement, construction, startup, validation) and GMP safety understanding.
- Flexibility to support 24/7 operations with occasional after-hours coverage.
Benefits:
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Time-off plans.
Application instructions:
- Apply at careers.amgen.com. Application deadline: none; accepting applications until sufficient number received or a candidate is selected.
Responsibilities include:
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including business cases, design requirements, and translation into equipment/system design, specification, construction support, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partners to ensure reliable plant operations.
- Develop equipment maintenance programs, ensure spare parts availability, and coordinate maintenance activities.
- Ensure systems are installed/operating safely and aligned with environmental health/safety practices, rules, and regulations.
- Ensure commissioning and qualification align with GMP requirements; 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 and ensure 24x7 day-to-day reliability of upstream and downstream systems.
- Lead technical problem-solving to reduce downtime for families of systems.
- Support plant readiness, quality, and regulatory compliance for internal/external/partner audits.
Basic qualifications:
- High school diploma/GED + 8 years Engineering/Maintenance experience OR
- Associate’s degree + 6 years Engineering/Maintenance experience OR
- Bachelor’s degree + 2 years Engineering/Maintenance experience OR
- Master’s degree
Preferred qualifications (skills/experience):
- BS in Chemical or Mechanical engineering.
- GMP biopharmaceutical production equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, TFF) plus related systems (autoclaves, CIP, washers, clean steam, water for injection).
- Experience with equipment/facility control systems operation, logic, and troubleshooting.
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems (change control, non-conformances, CAPA, qualifications/validation).
- Leadership, technical writing, communication/presentation; ability to work with minimum direction.
- Interpersonal/facilitation skills and collaborative, cross-functional teamwork.
- Analytical ability to evaluate sophisticated problems using multiple information sources.
- Engineering principles applied to system modifications, new process introductions, and capital projects.
- Capital project execution knowledge in GMP facilities (procurement, construction, startup, validation) and GMP safety understanding.
- Flexibility to support 24/7 operations with occasional after-hours coverage.
Benefits:
- Retirement and Savings Plan (company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Time-off plans.
Application instructions:
- Apply at careers.amgen.com. Application deadline: none; accepting applications until sufficient number received or a candidate is selected.