Manufacturing Engineer Jobs at Amgen with Visa Sponsorship
Manufacturing Engineer jobs at Amgen sit at the intersection of biotech science and large-scale production, covering process development, GMP compliance, and biologics manufacturing. Amgen has a consistent track record of sponsoring international engineers across multiple visa categories, making it a realistic target for qualified candidates who need work authorization.
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Get Access To All JobsINTRODUCTION
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
ROLE AND RESPONSIBILITIES
In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Apply inductive and deductive reasoning in the investigation process.
- Clear and concise technical writing.
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
BASIC QUALIFICATIONS
Doctorate degree
Or
Master’s degree & 2 years of directly related experience
Or
Bachelor’s degree & 4 years of directly related experience
Or
Associate’s degree & 8 years of directly related experience
Or
High school diploma / GED & 10 years of directly related experience
PREFERRED QUALIFICATIONS
- 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.), critical thinking, project management, and quality systems.
- Degree in Science or Engineering
- Experience leading complex investigations
- Experience using Veeva QMS for Deviation investigations and CAPAs
- Demonstrated project management ability
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
- Strong interpersonal skills
LOCATION
Location: US - North Carolina - Holly Springs
COMPENSATION
- Salary Range: 107,545.40 USD - 145,502.60 USD
WHAT YOU CAN EXPECT OF US
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements, where possible.
Join us for a career that defies imagination. Objects in your future are closer than they appear.
INTRODUCTION
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
ROLE AND RESPONSIBILITIES
In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Apply inductive and deductive reasoning in the investigation process.
- Clear and concise technical writing.
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
BASIC QUALIFICATIONS
Doctorate degree
Or
Master’s degree & 2 years of directly related experience
Or
Bachelor’s degree & 4 years of directly related experience
Or
Associate’s degree & 8 years of directly related experience
Or
High school diploma / GED & 10 years of directly related experience
PREFERRED QUALIFICATIONS
- 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.), critical thinking, project management, and quality systems.
- Degree in Science or Engineering
- Experience leading complex investigations
- Experience using Veeva QMS for Deviation investigations and CAPAs
- Demonstrated project management ability
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
- Strong interpersonal skills
LOCATION
Location: US - North Carolina - Holly Springs
COMPENSATION
- Salary Range: 107,545.40 USD - 145,502.60 USD
WHAT YOU CAN EXPECT OF US
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements, where possible.
Join us for a career that defies imagination. Objects in your future are closer than they appear.
See all Manufacturing Engineer Jobs at Amgen
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Manufacturing Engineer Jobs at Amgen.
Get Access To All JobsTips for Finding Manufacturing Engineer Jobs at Amgen
Align your credentials to GMP standards
Amgen's manufacturing roles operate under strict FDA Good Manufacturing Practice regulations. Before applying, document any GMP training, bioreactor experience, or cleanroom qualifications explicitly in your resume. Amgen's hiring teams screen for these signals early.
Target Amgen's process development pipeline roles
Amgen posts Manufacturing Engineer openings across drug substance, drug product, and process characterization tracks. Roles tied to biologics scale-up tend to see stronger sponsorship support, so filter your search by site location and therapeutic area to find the best-fit openings.
Request an E-3 LCA before your start date
If you're Australian, confirm with Amgen's immigration team that your Labor Condition Application is filed with DOL and certified before scheduling your consular appointment. LCA certification typically takes seven business days but can lag during peak periods.
Use Migrate Mate to surface Amgen openings by visa type
Filter Manufacturing Engineer roles at Amgen by the visa category you hold, whether that's H-1B, E-3, or F-1 OPT. Migrate Mate surfaces only roles where sponsorship has been confirmed, so you're not guessing about eligibility before you apply.
Prepare for PERM before your third year
Amgen routinely supports green card sponsorship for engineers on long-term tracks. If you're on an H-1B, discuss PERM initiation with your manager before your second year ends. DOL's PERM process can take 12 to 18 months, and early filing protects your priority date.
Negotiate OPT start timing around Amgen's onboarding cycles
Amgen's manufacturing sites typically onboard engineers on a quarterly schedule. If you're on F-1 OPT, coordinate your OPT start date with your DSO so your work authorization window aligns with Amgen's actual start date, not just the offer date.
Frequently Asked Questions
Does Amgen sponsor H-1B visas for Manufacturing Engineers?
Yes, Amgen sponsors H-1B visas for Manufacturing Engineer roles. The company files H-1B petitions on behalf of qualifying international candidates and has done so consistently across its U.S. manufacturing sites. If you're in the H-1B lottery pool or seeking a transfer from a current H-1B visa employer, Amgen is an active sponsor for this function.
How do I apply for Manufacturing Engineer jobs at Amgen?
Apply directly through Amgen's careers portal at amgen.com/careers. Search by job function, site location, or business unit to find active Manufacturing Engineer openings. You can also browse confirmed sponsorship roles on Migrate Mate, which filters Amgen listings by visa type so you can identify the positions most relevant to your work authorization status before submitting an application.
Which visa types does Amgen commonly use for Manufacturing Engineer roles?
Amgen sponsors a range of visa categories for Manufacturing Engineers, including H-1B, E-3 visa (for Australian citizens), TN visa (for Canadian and Mexican nationals), F-1 OPT and CPT for students, J-1 visa for exchange visitors, and employment-based Green Card pathways including EB-2 and EB-3. The right category depends on your citizenship, degree level, and career stage.
What qualifications does Amgen expect for Manufacturing Engineer positions?
Most Manufacturing Engineer roles at Amgen require a bachelor's degree in chemical engineering, bioengineering, or a related field, with direct experience in GMP environments. Familiarity with biologics manufacturing, process characterization, or technology transfer is a strong differentiator. Senior roles typically expect hands-on experience with upstream or downstream bioprocessing at commercial scale.
How do I handle visa timing if I receive an offer from Amgen?
Timing depends on your current visa category. H-1B transfers can begin on the filing receipt date, so you can start work without waiting for approval. For E-3 and TN visas, consular processing typically takes two to four weeks once your employer files the required documentation. USCIS premium processing is available for H-1B petitions if you need a faster decision, usually within 15 business days.