Sr Engineer I - Multiple Shifts
Amgen
5 hours ago
On-site
Holly Springs, NC
Operations
SR ENGINEER I – DOWNSTREAM – MULTIPLE SHIFTS
Responsibilities include:
- Provide system ownership for biopharmaceutical process equipment; identify/support/lead engineering improvements or upgrades including business case, design requirements, specification, 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; coordinate maintenance activities to keep systems operational.
- Ensure systems are installed and operating safely and comply 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.
- Reduce production downtime by leading/supporting technical root cause analysis and corrective/preventive action (CAPA).
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
- Provide rotational on-call support and ensure 24x7 reliability of upstream and downstream systems.
- Lead technical problem-solving to proactively reduce downtime for families of systems (RCA and CAPA).
- Ensure plant readiness and quality/regulatory compliance for internal, external agency, and partner audits.
- Lead new product/technology introductions including performance risk assessments, gap identification/remediation ownership, equipment modifications, and engineering runs.
Basic Qualifications:
- High school diploma/GED and 10 years of Engineering experience OR Associate’s degree and 8 years OR Bachelor’s degree and 4 years OR Master’s degree and 2 years OR Doctorate.
Preferred Qualifications:
- Bachelor’s degree in Chemical or Mechanical Engineering.
- 6+ years relevant experience with 5+ years in biopharmaceutical operations/manufacturing focused on downstream unit operations.
- GMP downstream facility equipment/system design and troubleshooting experience (e.g., cell culture reactors, centrifugation, chromatography, TFF, autoclaves, CIP systems, washers, clean steam, water for injection).
- Data-driven problem solving (Data Analytics, RCA, SPC, Six Sigma, Predictive Maintenance, etc.).
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP systems (change control, non-conformances, CAPA, qualifications/validation).
- Experience with system modifications, new process introduction, and oversight of capital projects; GMP capital project lifecycle (procurement, construction, startup, validation); safety understanding in GMP production facilities.
- Independent/organized; strong communication, facilitation, and teamwork; leadership and technical writing/presentation skills.
- Flexibility to support 24/7 operations with occasional after-hours coverage; domestic/international travel (~10%).
Applicable shifts:
- 4 days x 10 hours: Sunday through Wednesday
- 4 days x 10 hours: Wednesday through Saturday
Benefits (explicitly stated):
- Comprehensive employee benefits package including Retirement and Savings Plan (company contributions), group medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com.
Responsibilities include:
- Provide system ownership for biopharmaceutical process equipment; identify/support/lead engineering improvements or upgrades including business case, design requirements, specification, 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; coordinate maintenance activities to keep systems operational.
- Ensure systems are installed and operating safely and comply 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.
- Reduce production downtime by leading/supporting technical root cause analysis and corrective/preventive action (CAPA).
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
- Provide rotational on-call support and ensure 24x7 reliability of upstream and downstream systems.
- Lead technical problem-solving to proactively reduce downtime for families of systems (RCA and CAPA).
- Ensure plant readiness and quality/regulatory compliance for internal, external agency, and partner audits.
- Lead new product/technology introductions including performance risk assessments, gap identification/remediation ownership, equipment modifications, and engineering runs.
Basic Qualifications:
- High school diploma/GED and 10 years of Engineering experience OR Associate’s degree and 8 years OR Bachelor’s degree and 4 years OR Master’s degree and 2 years OR Doctorate.
Preferred Qualifications:
- Bachelor’s degree in Chemical or Mechanical Engineering.
- 6+ years relevant experience with 5+ years in biopharmaceutical operations/manufacturing focused on downstream unit operations.
- GMP downstream facility equipment/system design and troubleshooting experience (e.g., cell culture reactors, centrifugation, chromatography, TFF, autoclaves, CIP systems, washers, clean steam, water for injection).
- Data-driven problem solving (Data Analytics, RCA, SPC, Six Sigma, Predictive Maintenance, etc.).
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP systems (change control, non-conformances, CAPA, qualifications/validation).
- Experience with system modifications, new process introduction, and oversight of capital projects; GMP capital project lifecycle (procurement, construction, startup, validation); safety understanding in GMP production facilities.
- Independent/organized; strong communication, facilitation, and teamwork; leadership and technical writing/presentation skills.
- Flexibility to support 24/7 operations with occasional after-hours coverage; domestic/international travel (~10%).
Applicable shifts:
- 4 days x 10 hours: Sunday through Wednesday
- 4 days x 10 hours: Wednesday through Saturday
Benefits (explicitly stated):
- Comprehensive employee benefits package including Retirement and Savings Plan (company contributions), group medical/dental/vision, life/disability insurance, flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com.