Sr Engineer I - 2º Shift
Amgen
2 hours ago
On-site
Holly Springs, NC
Operations
SR ENGINEER I – DOWNSTREAM – 2nd SHIFT
What You Will Do / Responsibilities
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including translating design requirements into equipment/system specifications, and supporting construction, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations.
- Develop equipment maintenance programs; ensure spare parts availability and coordinate maintenance activities.
- Ensure safe installation/operation and alignment with EHS rules and regulations.
- Ensure commissioning and qualification align with GMP requirements and interact with regulatory inspectors.
- Identify performance risks and implement risk reduction strategies.
- Support problem solving to reduce production downtime, including 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 to ensure 24x7 reliability for upstream/downstream systems.
- Lead technical root cause analysis and corrective/preventive actions for families of systems.
- Support plant readiness and quality/regulatory compliance for internal/external/partner audits.
- Lead new product/technology introductions including performance risk assessments, gap identification/remediation, and implementation of modifications.
2nd Shift: 3pm to 11pm Monday through Friday
Basic Qualifications
- High school diploma/GED and 10 years engineering experience OR
- Associate’s degree and 8 years engineering experience OR
- Bachelor’s degree and 4 years engineering experience OR
- Master’s degree and 2 years engineering experience OR
- Doctorate degree
Preferred Qualifications / Required Skills
- Bachelor’s in Chemical or Mechanical Engineering.
- 6+ years relevant work experience with 5+ years in biopharmaceutical operations/manufacturing (Downstream unit operations).
- GMP biopharmaceutical production equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, TFF; autoclaves, CIP systems, washers, clean steam, water for injection).
- Data-driven problem analysis and solutions (e.g., RCA, SPC, Six Sigma, predictive maintenance, data analytics).
- Regulated environment experience (e.g., cGMP/OSHA/EPA) and GMP quality system knowledge (change control, non-conformances, CAPA, qualifications/validation).
- Experience designing/implementing system modifications, introducing new processes, and overseeing capital projects; understanding GMP capital project lifecycle (procurement, construction, startup, validation).
- Understanding of safety requirements in GMP biopharmaceutical facilities.
- Independent, organized, able to multi-task; strong communication/facilitation/teamwork; leadership and technical writing/presentation skills.
- Schedule flexibility for 24/7 operations (occasional after-hours coverage); domestic/international travel (~10%).
Benefits (Total Rewards Plan)
- Retirement and Savings Plan with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales roles).
- Stock-based long-term incentives; award-winning time-off plans.
- Flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number are received or a candidate is selected.
What You Will Do / Responsibilities
- Provide system ownership for biopharmaceutical process equipment; identify, support, and/or lead engineering improvements/upgrades, including translating design requirements into equipment/system specifications, and supporting construction, startup, and validation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations.
- Develop equipment maintenance programs; ensure spare parts availability and coordinate maintenance activities.
- Ensure safe installation/operation and alignment with EHS rules and regulations.
- Ensure commissioning and qualification align with GMP requirements and interact with regulatory inspectors.
- Identify performance risks and implement risk reduction strategies.
- Support problem solving to reduce production downtime, including 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 to ensure 24x7 reliability for upstream/downstream systems.
- Lead technical root cause analysis and corrective/preventive actions for families of systems.
- Support plant readiness and quality/regulatory compliance for internal/external/partner audits.
- Lead new product/technology introductions including performance risk assessments, gap identification/remediation, and implementation of modifications.
2nd Shift: 3pm to 11pm Monday through Friday
Basic Qualifications
- High school diploma/GED and 10 years engineering experience OR
- Associate’s degree and 8 years engineering experience OR
- Bachelor’s degree and 4 years engineering experience OR
- Master’s degree and 2 years engineering experience OR
- Doctorate degree
Preferred Qualifications / Required Skills
- Bachelor’s in Chemical or Mechanical Engineering.
- 6+ years relevant work experience with 5+ years in biopharmaceutical operations/manufacturing (Downstream unit operations).
- GMP biopharmaceutical production equipment/system design and troubleshooting (e.g., cell culture reactors, centrifugation, chromatography, TFF; autoclaves, CIP systems, washers, clean steam, water for injection).
- Data-driven problem analysis and solutions (e.g., RCA, SPC, Six Sigma, predictive maintenance, data analytics).
- Regulated environment experience (e.g., cGMP/OSHA/EPA) and GMP quality system knowledge (change control, non-conformances, CAPA, qualifications/validation).
- Experience designing/implementing system modifications, introducing new processes, and overseeing capital projects; understanding GMP capital project lifecycle (procurement, construction, startup, validation).
- Understanding of safety requirements in GMP biopharmaceutical facilities.
- Independent, organized, able to multi-task; strong communication/facilitation/teamwork; leadership and technical writing/presentation skills.
- Schedule flexibility for 24/7 operations (occasional after-hours coverage); domestic/international travel (~10%).
Benefits (Total Rewards Plan)
- Retirement and Savings Plan with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales roles).
- Stock-based long-term incentives; award-winning time-off plans.
- Flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number are received or a candidate is selected.