Sr Engineer - Holly Springs, NC

Job Description

SR ENGINEER I, PROCESS DEVELOPMENT (DOWNSTREAM)

• Support technology transfer, process validation, and plant start-up
• Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
• Partner with cross‑functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Provide on‑the‑floor process support as required
• Ensure safety and compliance of process development activities
• Collaborate with other site‑functions and network drug substance teams in delivering plant goals
• Support regulatory filing, inspection, and other CMC activities

• High school diploma / GED and 10 years of biologics process development or commercial‑scale technical support experience OR
• Associate’s degree and 8 years of biologics process development or commercial‑scale technical support experience OR
• Bachelor’s degree and 4 years of biologics process development or commercial‑scale technical support experience OR
• Master’s degree and 2 years of biologics process development or commercial‑scale technical support experience OR
• Doctorate degree
• Preferred:
  Master’s degree in Engineering or Science discipline
• 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• In‑depth expertise in biologics process purification processes
• Experience in process scale‑up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
• Ability to apply engineering principles and statistical analysis in resolving complex issues
• Knowledge in regulatory filings and inspections
• Knowledge in broad aspects of biologics processing, e.g., cell culture, analytical methods, or product quality attributes
• Familiarity in operational aspects of commercial biopharma manufacturing (e.g., process automation, equipment, single use)

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $140,465 to $190,041. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities that may include:

• A 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
• Flexible work models, including remote and hybrid as possible

City:
Holly Springs

State:
North Carolina

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