Process Development Engineer

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 awardwinning 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.

Process Development Engineer

What you will do

Lets do this! Lets change the world! As part of Amgens Process Development organization Drug Product Technologies (DPT) is seeking a highly dynamic Engineer to provide process development support to Amgens clinical and commercial sterile fillfinish manufacturing plant in Thousand Oaks CA. The candidate will play a key role in bringing a wide variety of highquality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing technology transfer process characterization process validation and continuous process verification. This position is based in Thousand Oaks CA at the Amgen headquarters.

Key Responsibilities:

New Product Introductions

• Characterizes drug product process parameters for DP manufacturing process designs and executes offline and online studies to fully characterize the process and ensure successful technology transfer.

• Designs implements and documents offline and onsite DP characterization studies.

• Designs plans and provides floor support to onsite engineering machinability and process performance qualifications (PPQ) runs required to ensure successful product commercialization.

• Supports makeabatch exercises to determine facility fit and identify gaps.

Process Validation & Regulatory Support

• Development of validation plans PPQ protocols and reports for commercial manufacturing in alignment with GMP quality system documentation standards.

• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures including safety and training.

• Ensure that the site meets the quality requirements of its customers and applicable laws/regulations (FDA EU & global standards).

• Participate and lead in validation crossfunctional teams at the site to ensure alignment to required policies and procedures.

• Provide recommendations to site validation guidance documents.

• Be a key contributor to regulatory filings as part of the NPI process by authoring editing and submitting filings as well as assist in responding to regulator questions as required.

• Support PAI and GMP inspections in the plant.

Manufacturing Support

• Lead and implement characterization studies on the floor including process characterization tech transfer studies process validation and ongoing commercial manufacturing.

• Lead or assist in process related deviations exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment.

• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement.

• Collaborate with manufacturing as well as all support functions such as engineering quality and drug product technologies to provide robust and coordinated support to manufacturing.

• Identifies and implements new process improvements for current and new sterile operations for increased reliability agility and efficiency in plant operations.

• Work with multifunctional teams conducting FMEAs risk assessments author technical protocols reports and CMC subsections and present findings and project status.

Aseptic DP Technology leadership

• Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global crossfunctional teams for shared best practices in technical advancements across Amgen clinical and commercial fillfinish plants.

• Drive innovations in aseptic processes technologies and techniques all in alignment with evolving regulatory expectations and internal quality standards leading to continuous improvement in GMP drug product manufacturing.

• Work individually and with a team of engineers to design implement and document primary data packages related to new technology development while demonstrating specific expertise in aseptic processing and unit operations characterization

• Supports expansion projects by supporting equipment user requirements FAT Process Characterization and Validation in all sterile fill finish processing areas.

DP Network support

• Establishes strong working relationships with partner sites across DP Manufacturing network to champion the sharing of technical best practices improvement opportunities and lessons learnt to deliver highquality manufacturing processes.

• Acts as single Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing formulation filling vials/syringes/devices lyophilization and inspection.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Masters Degree OR

• Bachelors Degree and 2 years of Scientific Engineering and/or Operations experience OR

• Associates degree and 6 years of Scientific Engineering and/or Operations experience OR

• High school diploma/GED and 8 years of Scientific Engineering and/or Operations experience

Preferred Qualifications:

• Educational background in Chemical Engineering Biomedical Engineering Biotechnology or related technical field of study in biotechnology life sciences or related field.

• 2 years of experience in the pharmaceutical or biotechnology industry that includes elements of process development process characterization and technical transfers to manufacturing sites

• Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw formulation/mixing filtration filling lyophilization capping and visual inspection.

• Project management skills including the ability to handle numerous projects and evaluate project resource requirements.

• Demonstrated ability in providing leadership to multifunctional teams to advance complex projects to completion and influencing decisions.

• Ability to lead innovation collaborate in a multifunctional team environment and act on dynamic information at a rapid pace

• Ability to independently design and implement characterization studies author characterization protocols process transfer documents application notes and technical reports

• Proficiency in technical problem solving critical thinking and delivery of technical solutions with limited oversight

• Capable of organizing and communicating complex technical concepts to enable business decisions

• Solid understanding of Quality systems and Drug Product Manufacturing (GMP).s

• Demonstrated ability to use interpersonal skills to build strong technical relationships.

• Selfmotivation adaptability and a positive demeanor.

• Excellent communication skills both oral and written.

• Ability to elevate relevant issues to project lead and linemanagement.

• Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and align with company policies.

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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove ageidentifying 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.

Application deadline

Amgen anticipates accepting applications until May 5 2025; however we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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.

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