Senior Engineer Confipen Platform and Lifecycle Management

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Lets do this. Lets change the this role the Sr. Process Development Engineer reports to the Associate Director of Process Development and serves as the technical leader and Subject Matter Expert (SME) for combination products drug delivery devices and automated assembly technologies supporting commercial Combination Product and Final Drug Product (FDP) operations at the Amgen Ohio site.

Job Details:

The senior engineer will lead the design development and lifecycle management for commercial Confipen devices and combination products assembly and packaging lines.

The scope of the position includes Confipen devices packaging machinery. The qualified candidate will be part of a development and implementation site Process Development engineering team that supports final product assembly and packaginglifecycle process support. These responsibilities include but are not limited to:

• Advising on combination product requirements and specifications
• Leading product testing to demonstrate product safety performance and efficacy
• Analyzing data to support design acceptance performance capability and failure analysis
• Creating and executing test protocols and methods
• Support manufacturing scale-up and NPI launches
• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution
• Leads troubleshooting for assembly testing and packaging equipment
• Engaging suppliers and development partners regarding component specifications and quality levels
• Provides authorship and expert technical leadership for regulatory filings
• Managing project scope schedule and budget
• Owns and support quality records change records and deviations
• Leads RCA process related to Quality events and device failures to identify corrective actions
• Interface with Process Development and external partners as a technical subject matter expert.
• Leads continuous improvement activities
• Lead troubleshooting activities for line process and machinery
• Mentor junior engineers and provide technical guidance across multiple engineering disciplines

Essential skills and experience:

• Application of good documentation practice in creation and maintenance of technical design records including but not limited to design input requirements design specifications verification protocols and reports design transfer plans
• Proven ability to lead cross-functional teams including scientists engineers suppliers project managers manufacturing marketing regulatory affairs and quality to enable development efforts
• Proficiency in the interpretation and application of technical standards (e.g. ASTM ISO)
• Capability to use design software (e.g. SolidWorks) create and interpret engineering drawings
• Knowledge of statistical methods such as capability analysis Design of Experiments Statistical Process Control
• Understanding of risk management principles to be able to support product risk assessment activities
• Experience leading root cause investigations design of experiments coordinate design improvements with development partners and lead implementation
• Experience creating and managing project plans
• Strong written and verbal communication skills

This position is located in New Albany OH and requires up to 10% domestic and international travel.

Basic Qualifications:

Doctorate degree

OR

Masters degree & 2 years of Engineering and/or Operations experience

OR

Bachelors degree & 4 years of Engineering and/or Operations experience

OR

Associates degree & 8 years of Engineering and/or Operations experience

OR

High school diploma / GED and 10 years of Engineering and/or Operations experience

Preferred Qualifications:

• Bachelors degree in engineering or other science-related field with 7 years of relevant work experience with 5 years of experience in operations/manufacturing environment
• 3 years of experience in medical device pharmaceutical or a similar regulated industry
• Background in development and commercialization of medical devices and knowledge of manufacturing processes
• Understanding of the following standards and regulations:
  • Quality System Regulation 21CFR820
  • Quality Management System for medical device/component manufacturers - ISO 13485 Risk Managementfor Medical Devices ISO 14971
  • EU Medical Device Regulation 2017/745
• Excellent communication and technical writing skills
• Ability to work independently and across functional teams
• 3 years of experience in drug containers drug delivery or related functions.
• 3 years of experience in testing equipment methods and mechanical design
• Project management experience/ Multi-tasker to enable managing multiple deliverables/priorities
• Proficiency in Solidworks/CAD/Drawings/Assemblies
• Design for Manufacturing (DFX)/Design for Assembly (DFA)
• Knowledgeable about Design Controls / Combination Products
• Knowledgeable about Regulatory Standards and Compendial Requirements Problem solving / Root Cause Analysis
• Flexible/Highly adaptive to continuous changing priorities/environment
• Strong team player interpersonal and communication skills
• Strong oral and written communication skills including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
• Strong mechanical engineering and material science knowledge

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 well support your journey every step of the way.

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 including remote and hybrid work arrangements where possible

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world 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. Together we compete in the fight against serious disease.

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. Please contact us to request accommodation.

Salary Range