Manufacturing Specialist-Process Engineer

About the role

Join Amgen’s mission of serving patients. At Amgen, 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 a 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. This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer/new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance.

Responsibilities

• Applied Process Expertise
  • As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations.
  • Assess process performance by observing floor operations, reviewing performance data, and providing troubleshooting support.
  • Evaluate, plan, and implement solutions for process improvement opportunities.
  • Assist in generating training materials and/or providing training on scientific or technical aspects of the process.
  • Complete risk evaluations for new processes or changes to existing processes and issue summary reports.
• Projects and Initiatives
  • Bring continuous improvement initiatives for cost reduction or cycle time reduction.
  • Participate in the assessment or implementation of special projects or initiatives.
• Process Monitoring
  • Support process monitoring parameters and control limits based on critical metrics and recommend improvements.
  • Collect process-monitoring data and support the assessment of deviations.
  • Provide support for timely process monitoring quarterly reports.
• Technology Transfer / New Product Introductions & Process or Equipment Modifications
  • Participate in technology transfer/NPI processes to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Non-Conformance and CAPA
  • Ensure all non-conformances are triaged within the established goal.
  • Assist with investigations, corrective actions, and NC/CAPA closure within established goals.
  • Monitor and communicate incident trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Process Validation
  • Assist with process validation and generation of process validation protocols and reports.
  • Support collection and analysis of process validation data.
• Regulatory
  • May participate in regulatory inspections.
• Change Control
  • As manufacturing change owner, provide assessments on CCRB records impacting the process.

Requirements

Basic Qualifications

• Doctorate degree
• Or Master’s degree and 2 years in Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Or Bachelor’s degree and 4 years in Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Or Associate’s degree and 8 years in Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Or High school diploma/GED and 10 years in Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.

Skills

Preferred Qualifications

• Detailed technical understanding of bioprocessing and manufacturing operations.
• Develop, manage, and implement process improvements.
• Experience with Lean principles (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques.
• Experience participating and helping lead cross-functional teams.
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
• Experience with change control process and change management.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Project management skills.
• Excellent organizational, technical writing, presentation, and verbal skills.
• Knowledge of data analysis and control charting.

Benefits

• 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.
  • 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.

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 towards retirement or other goals, work/life balance, and career development opportunities.

About Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

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. 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.