Engineer Process Development (Commissioning, Qualification, and Validation)

Career Category

Job Description

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. 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.

Engineer - Process Development (Commissioning Qualification and Validation)

What you will do

Lets do this. Lets change the this role you will support the commissioning qualification and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle.

As a key contributor to AOHs growth you will play an essential role in technical transfer equipment startup process validation and continuous improvement across automated device assembly packaging and FDP manufacturing operations. Your work will help ensure reliable compliant and efficient production systems that support Amgens mission of serving patients.

Key responsibilities of this role include:

Commissioning Qualification & Validation (CQV)

• Complete commissioning activities and author/implement IQ/OQ/PQ protocols validation plans and lifecycle documentation.
• Maintain validated state of equipment and processes through periodic review and documentation updates.
• Participate in equipment and system design review supporting requirements definition and CQV strategy alignment.
• Support and participate in FAT/SAT equipment installation and startup readiness.
• Collect and analyze process and equipment data to support validation characterization and sustained performance.

Technical Transfer & Process Support

• Support technical transfer of FDP and combination product processes into AOH ensuring CQV deliverables are met.
• Perform data collection and process characterization to support new equipment and process introductions.
• Trouble shoot device assembly and packaging equipment through engineering fundamentals and multi-functional support.
• Provide technical feedback into change control deviations CAPA and risk assessments (as applicable to validation activities).

Project Management & Multi-Functional Collaboration

• Support CQV project planning schedule alignment and execution for new or modified equipment and systems.
• Partner with Manufacturing Process Development Engineering and Quality to ensure project deliverables are met on time.
• Maintain effective communication with AOH site teams and the broader Amgen network to ensure alignment on technical deliverables.
• Support documentation reviews supplier interactions and internal readiness for inspections or audits.

Technical Expertise & Equipment Support

• Serve as a technical resource for automated and semi-automated device assembly and packaging equipment.
• Support trouble shooting and lead investigations for technical issues impacting equipment performance or reliability.
• Review vendor documentation test protocols and engineering drawings to ensure compliance with CQV requirements.
• Evaluate equipment and process performance trends to identify improvement opportunities.

Operational Excellence & Continuous Improvement

• Identify and support improvements in throughput reliability and process capability across packaging and assembly operations.
• Participate in Lean Six Sigma and Operational Excellence initiatives to strengthen equipment performance and CQV processes.
• Support data-driven decision-making through process monitoring trend analysis and equipment performance assessments.
• Recommend enhancements to CQV procedures templates and standard methodologies to increase efficiency and compliance.

Partner Relationships & Collaboration Network

• Build collaborative relationships with key site and network groups including:
• Site Process Development
• Manufacturing & Quality Assurance
• Engineering & Maintenance
• Global Technical & Validation Networks
• External Equipment Suppliers
• Leverage this network to support equipment qualification technical trouble shooting validation standardization and performance trending.

Travel: Approximately 20%

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Process Development professional we seek is a leader with these qualifications.

Basic Qualifications:

Masters degree

Or

Bachelors degree and 2 years in a GMP-regulated environment

Or

Associates degree and 6 years in a GMP-regulated environment

Or

High school diploma / GED and 8 years in a GMP-regulated environment

Preferred Qualifications:

• Understanding of combination product assembly technologies automated and semi-automated equipment and packaging operations.
• Experience supporting CQV activities including protocol writing execution and data analysis.
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Demonstrated ability to contribute to cross-functional technical projects.
• Experience working with manufacturing equipment suppliers
• Ability to learn rapidly in a complex fast-moving GMP environment.
• Operational Excellence mindsetLean/Six Sigma exposure preferred.
• A passion to deliver an excellent work product and develop others with an infective positive attitude.

What you can expect of 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 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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

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