Specialist Mfg I

BioSpace; 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 program

Flexible work arrangements

Job summary

Amgen is seeking a Specialist Mfg I to lead planning and execution on the production floor, coordinating with Quality, Process Engineering, Regulatory and Process Development. You will manage change controls, BOMs, and manufacturing documents while driving continuous improvement and risk mitigation.

The role requires a Master’s degree with 2 years of related experience, and hands-on use of Veeva/CDOCs, Smartsheets, DeltaV, and CI tools to support NPI programs and plant performance.

Qualifications

• Master's degree in Engineering Management, Biology or related field with 2 years of related experience.
• Experience creating and managing change control records and manufacturing documents in Veeva/CDOCs.
• Familiarity with CAPA, deviations, and cross functional project delivery.

Responsibilities

• 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 preparation, implementation, sustainment and lessons learned.
• 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 organizations in prioritization and execution to maximize plant performance and capacity.
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements.
• Own and author critical SOPs and training documentation.
• Anticipate risk and build contingencies to mitigate impact.

Skills

Cross-functional collaboration

Data analysis

Problem solving

Quality mindset

Education

Master's degree in Engineering Management,Biology or related field

Tools

Veeva/CDOCs

CDOCs

Smartsheets

DeltaV

PI Vision

Spotfire

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

• 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 build contingencies to help mitigate impact.

Requirements: Masters 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 Smartsheets.
• 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; and
• 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 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

careers.amgen.com

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.