Manufacturing Specialist-Process Engineer

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.

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.

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

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.

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.

Assist with the process validation and generation of process validation protocols and reports. Support collection and analysis of process validation data.

May participate in regulatory inspections.

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.

Doctorate degree

Masters degree and 2 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

Bachelors degree and 4 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

Associates degree and 8 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

High school diploma / GED and 10 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

• 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

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.

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 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.

Salary Range