Specialist Mfg I

Amgen Inc.; West Greenwich (RI); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus eligibility

Job summary

Amgen is seeking a Specialist Mfg I to lead and support key initiatives on the production floor. You will liaise with cross-functional teams to ensure program preparation, implementation, sustainment, and lessons learned for NPI/PRI projects.

You will analyze data to evaluate process performance trends, own quality records, and collaborate with Quality, Process Engineering, Regulatory, and Process Development to drive improvements.

Qualifications

• Master’s degree in Engineering Management, Biology, or related field and 2 years of relevant experience.
• Create and manage change control records in Veeva/CDOCs systems.
• Manage manufacturing documents and revision of BOMs in Veeva/CDOCs.
• Experience with critical manufacturing operations, CAPA and Deviation handling.
• Technical expertise on mechanical/ automated systems impacting Manufacturing/NPI projects including DeltaV.
• Troubleshoot issues using DeltaV, PI Vision and Spotfire.
• Lead cross-functional deliverables to meet project timelines.
• Facilitate MS Teams and in-person meetings for NPI programs.

Responsibilities

• Lead and support planning and execution of key initiatives on the production floor.
• Coordinate with cross-function teams to prepare, implement, sustain, and share lessons learned for NPI/PRI programs.
• Provide and analyze data to support management evaluation of process performance trends.
• Own quality records (change control, CAPA, deviations) and deliver to timelines.
• Support AR5/AR30 manufacturing in prioritization and execution to maximize plant performance and capacity.
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements.
• Support front-line managers through on-the-floor presence.
• Own and author critical SOPs and supporting documentation/training.

Skills

Cross-functional leadership

Data analysis

On-floor presence

Change control

CAPA

Deviations handling

Education

Master's degree in Engineering Management

Tools

Veeva/CDOCs

Smartsheet

DeltaV

PI Vision

Spotfire

Job description

Career Category

Manufacturing

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. 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 Mfg I

Duties:

• Lead and support planning and execution of key initiatives with cross functional teams at the production floor
• Liaison at the floor and with cross function teams to assure program (NPI/PRI) preparation, implementation, sustainment and capture and share lessons learned
• Provide and analyzes data to support management evaluation of process performance trends
• Provide subject matter expertise for area of responsibility
• Own quality records (change control, CAPA, deviations) and deliver to timelines
• Support AR5/AR30 manufacturing organizations in the prioritization and execution of these activities to maximize plant performance and plant capacity
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements
• Support of front-line managers through on the floor presence
• Own and author critical standard operating procedures and supporting documentation/training
• Anticipate risk and builds contingencies to help mitigate impact

Requirements: Master’s degree (or foreign equivalent) in Engineering Management, Biology or a related field & 2 years of experience in the job offered or in a Specialist Manufacturing related occupation. The position requires 2 years of experience in the following:

• Create and manage change control records in Veeva/CDOCs systems
• Own change control records to support Manufacturing/NPI programs or other parallel projects
• Create and update Manufacturing documents/revision of process Bill of Materials (BOM) in Veeva/CDOCs, additionally support new Smart BOM project in Smartsheet’s
• Management of manufacturing document workflows in CDOCs/Veeva
• Experience in critical manufacturing operations, continuous improvement, CAPA and Deviation
• Technical Expertise on mechanical and automated functionality of systems impacted by Manufacturing/NPI project including chromatography, Harvest through DeltaV
• Utilize expertise to troubleshoot issues through DeltaV, PI Vision and Spotfire
• Support management of cross functional deliverables to meet project timelines as managed through Veeva and Smartsheets
• Facilitate Microsoft Teams and in person meetings associated with NPI programs

Job type: Full-Time position.

The annual salary range for this position in the U.S. is $107,545.00 - $145,503.00 per year.

Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

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.

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 sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

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.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.