Manufacturing Specialist-Process Engineer

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Specialist in Manufacturing to help execute manufacturing/quality systems, drive continuous improvement, and support technology transfer and process validation. You will apply scientific expertise, manage process changes, and contribute to training and CAPA programs.

The role requires strong GMP knowledge, cross-functional collaboration, and project management skills to support regulatory readiness and continuous production improvements.

Qualifications

• Doctorate or equivalent with extensive manufacturing/quality experience in biotech/pharma.
• Progressive experience in process validation and technology transfer.
• Strong knowledge of GMP and regulatory expectations.

Responsibilities

• Support execution of manufacturing/quality systems including continuous improvement and tech transfer.
• Apply analytical and troubleshooting skills to ensure process performance.
• Develop training materials and perform or coach training on scientific/technical topics.
• Lead/process ownership for key systems and drive CAPA activities.
• Participate in regulatory inspections and change control processes.

Skills

Bio-processing

Process improvement

Lean Six Sigma

Cross-functional leadership

Regulatory knowledge

GMP operations

Project management

Technical writing

Data analysis

Control charts

Education

Doctorate degree

Master's degree + 2 years in Eng/Manufacturing/Quality

Bachelor's degree + 4 years in Eng/Manufacturing/Quality

Associate's degree + 8 years in Eng/Manufacturing/Quality

High school diploma/GED + 10 years in Eng/Manufacturing/Quality

Job description

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. 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, 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.

Specialist, Manufacturing

What you will do

Lets do this. Lets 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
• Masters degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Or
• Bachelors degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Or
• Associates 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, well support your journey every step of the way.

Benefits

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.