Sr. Associate - Manufacturing - Engineering Support

Amgen SA; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Retirement and Savings Plan

Job summary

Amgen seeks a Sr. Associate - Manufacturing - Engineering Support to help execute manufacturing and quality systems across ongoing operations in New Albany, OH.

You will apply process, operational, and scientific expertise to support tech transfer, validation, and continuous improvement activities. You will own documentation updates, perform risk assessments, and assist with CAPA investigations, regulatory interactions, and change control while collaborating with cross-functional teams to drive

Qualifications

• High school/GED + 4 years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Associate’s + 2 years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Bachelor’s + 6 months in engineering, manufacturing, packaging or quality in pharma/biotech.
• Master's degree holders qualify for the role.
• Knowledge of Lean, Kaizen, Six Sigma and operational excellence preferred.
• Experience with cross-functional teams and change control processes.
• Strong GMP production operations knowledge and regulatory awareness.

Responsibilities

• Execute manufacturing/quality systems such as continuous improvement, technology transfer, NPI, and process validation.
• Maintain procedures reflecting current operations; perform risk evaluations and training.
• Support tech transfer and NPI for docs, training, equipment modifications.
• Participate in cost/time reduction initiatives and special projects.
• Assist with CAPA/NC investigations and trend evaluations.
• Support regulatory inspections and CCRB-related activities.
• Provide training materials and deliver technical trainings.

Skills

Lean principles

Six Sigma

GMP operations

Regulatory knowledge

Data analysis

Project management

Cross-functional collaboration

Technical writing

Process validation

Education

High school/GED with 4 years in Eng, Manufacturing, Packaging or Quality

Associate’s + 2 years in Eng, Manufacturing, Packaging or Quality

Bachelor’s + 6 months in Eng, Manufacturing, Packaging or Quality

Master's

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.

Sr. Associate - Manufacturing - Engineering Support

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:

High school/GED + 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

OR
Associate’s + 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

OR
Bachelor’s + 6 months in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology

OR
Master's

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. Refer to the Work Location Type in the job posting to see if this applies.

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.