Engineer - Process Development (Commissioning, Qualification, and Validation)

Amgen; New Albany (OH); In loco; USD 88.000 - 119.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus program

Stock‑based incentives

Flexible work models

Benefits package

Descrizione del lavoro

Amgen Ohio site is seeking a Process Development Engineer to lead CQV activities for FDP equipment and processes. You will drive commissioning, qualification, and validation across automated packaging and assembly, ensuring compliant, reliable production.

The role emphasizes technical transfer, data analysis, and continuous improvement within a GMP framework. You will partner with Manufacturing, Process Development, Engineering, and Quality to meet deliverables, participate in inspections, and

Competenze

• Master’s degree required.
• Bachelor’s degree and 2 years in a GMP‑regulated environment.
• Associate’s degree and 6 years in a GMP‑regulated environment.
• High school diploma / GED and 8 years in a GMP‑regulated environment.

Mansioni

• 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.
• Support and participate in FAT/SAT, equipment installation, and startup readiness.
• Provide technical feedback into change control, deviations, CAPA, and risk assessments (as applicable to validation activities).
• Project Management & Multi‑Functional Collaboration CQV project planning, schedule alignment, and execution.

Formazione

Master’s degree

Bachelor’s degree and 2 years in a GMP‑regulated environment

Associate’s degree and 6 years in a GMP‑regulated environment

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

Descrizione del lavoro

Career Category Process Development Job Description Join Amgen’s 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. 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. Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you’ll 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 Let’s do this. Let’s change the world. In 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 AOH’s 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 Amgen’s 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

• Master’s degree
• Bachelor’s degree and 2 years in a GMP‑regulated environment
• Associate’s degree and 6 years in a GMP‑regulated environment
• 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 mindset—Lean/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

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.

Salary Range 88,281.00USD -119,439.00 USD

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.

Sponsorship for this role is not guaranteed.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.