PD Sr Engineer

About the role

Join Amgens Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. 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. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Responsibilities

• Lead bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide a risk-based approach to microbial assessments
• Act as manufacturing process subject matter expert to support quality partners and provide operational and engineering understanding to assess the overall capability to clear bioburden and their potential by-products
• Work cross-functionally to support the drafting of microbial impact assessment utilizing a risk-based approach
• Perform trending of bioburden instances within manufacturing space and escalate concerning objectionable microorganisms
• Lead the generation, resolution, and closure of PD deviations
• Support upstream and/or downstream process engineering teams for process monitoring or technical study activities
• Provide process validation support as required for documentation or floor activities
• Manage and mentor an engineer member
• Support ANC PD business strategy activities to improve network practices, develop digital tools, and optimize ANC PD business operations

Requirements

• High school diploma/GED and 10 years of biologics process development, process engineering, or process validation experience
• Associates degree and 8 years of biologics process development, process engineering, or process validation experience
• Bachelor's degree and 4 years of biologics process development, process engineering, or process validation experience
• Masters degree and 2 years of biologics process development, process engineering, or process validation experience
• Doctorate degree

Qualifications

• Basic Qualifications: Experienced scientific professional with 10+ years of biologics process development, process engineering, or process validation experience
• Preferred Qualifications: 5+ years of experience in an Upstream (Cell Culture), Downstream (Purification), or process validation role supporting biopharmaceutical processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream or downstream manufacturing processes
• Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
• Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
• Independently motivated with successful ability to multi-task and work in teams
• Demonstrated leadership skills and decision-making experience
• Experience with managing
• Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes
• Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

Skills

• Strong understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing
• Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
• Independent problem-solving and decision-making skills
• Effective communication and collaboration skills
• Experience with process validation and regulatory compliance

Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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 of 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 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 where possible.