Manufacturing Specialist-Process Engineer

Amgen; New Albany (OH); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Discretionary annual bonus program

Stock-based long-term incentives

Retirement and savings plan

Flexible work model

Job summary

Amgen Specialist, Manufacturing role focused on executing manufacturing and quality systems, supporting continuous improvement, technology transfer and process validation. You will apply technical expertise to ensure compliant operations, training, and data-driven decision making.

The role emphasizes process ownership, CAPA, change control, and collaboration with cross-functional teams to drive efficiency and quality across manufacturing lines.

Qualifications

• Doctorate or Master’s with 2 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech; or Bachelor’s with 4 years; or Associate’s with 8 years; or high school with 10 years.
• Detailed technical understanding of bio-processing and manufacturing operations.
• Experience with Lean principals (Kaizen, Six Sigma) and problem-solving.
• Experience in cross-functional teams, GMP production operations, and regulatory interactions.

Responsibilities

• Apply process expertise: author and revise manufacturing procedures; assess performance; troubleshoot and improve processes.
• Lead continuous improvement initiatives for cost/cycle time reductions.
• Monitor processes and support deviations, quarterly reports, and data reviews.
• Assist technology transfer and NPI processes, documenting requirements and coordinating training.
• Support change control records and root-cause analyses for investigations.
• Assist process validation and regulatory inspections as needed.

Skills

Lean principles

Problem solving

Cross-functional collaboration

GMP knowledge

Project management

Data analysis

Regulatory knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Career Category Manufacturing Job Description 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. 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. 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.

Specialist, Manufacturing

What you will do Let’s do this. Let’s change the world. 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. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems.

Responsibilities may include, but are not limited to:

• Applied Process Expertise As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Complete risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.

• Projects and Initiatives Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.

• Process Monitoring Support process monitoring parameters and control limits based off critical metrics and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely process monitoring quarterly reports.

• Technology Transfer / New Product Introductions & Process or Equipment Modifications Participate in technology transfer / NPI process 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 that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

• Process Validation Assist with the 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.

What we expect of you We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

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.

Preferred Qualifications

• Detailed technical understanding of bio-processing and manufacturing operations
• Develop, manage, and implement process improvements
• Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
• Experience in 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

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, we’ll support your journey every step of the way. 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 107.545,40USD -145.502,60 USD

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.

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.

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen