Amgen
Senior Engineer System Owner Compliance
US - North Carolina - Holly Springs · Senior
Sponsorship not specifiedDetected 8 hours ago
Data AnalysisSupply ChainProcess ImprovementProcurementCustomer SupportMechanical DesignGMPResearchLeadershipCommunicationCollaborationWritingOSHA
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38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
- With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
- Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.
Responsibilities
- Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Maintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation.
- Partner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections.
- Own facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems.
- This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Serve as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations.
Requirements
- High school diploma / GED and 10 years Engineering experience OR
- Associate's degree and 8 years of Engineering experience OR
- Bachelor's degree and 4 years of Engineering experience OR
- Master's degree and 2 years of Engineering experience OR
- Doctorate degree
Nice to have
- Bachelor's degree in Chemical or Mechanical Engineering
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Great teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Ability for domestic/international travel
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
Compensation
- 115,494.60USD -156,257.40 USD
Benefits
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
Company info
- Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.