Manufacturing Senior Associate 12 hour PM shift

Amgen; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Total Rewards Package

Comprehensive benefits

Flexible work models where possible

Job summary

Amgen is seeking a Manufacturing Senior Associate to lead and manage all aspects of a device assembly and packaging line. You will ensure full cGMP compliance, supervise technicians, and oversee production equipment to meet schedules.

Responsibilities include equipment setup, uptime maintenance, safety compliance, and collaboration with Quality, Engineering, and Regulatory staff to resolve issues promptly. Strong emphasis on Lean and continuous improvement.

Qualifications

• Bachelor’s degree in Chemical Engineering, Industrial Engineering or Life Sciences.
• Master’s degree may be preferred or required depending on role progression.
• Experience with GMP/CGMP environments is highly valued.

Responsibilities

• Lead manufacturing operations on the production floor and oversee equipment setup and operation.
• Maintain machine uptime and clear faults on automated equipment.
• Ensure compliance with safety and quality procedures at all times.
• Collaborate with Quality, Engineering and Manufacturing Support to resolve events.
• Provide training and technical support to manufacturing staff.
• Drive continuous improvement through Lean and OE initiatives.

Education

Bachelor's degree in Chemical Engineering, Industrial Engineering or Life Sciences

Master's degree

Tools

MES

LIMS

Maximo

CCMS

SAP

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

Manufacturing Senior Associate

What you will do

In this role you will be managing and leading all aspects of a device assembly & packaging line. Responsibility includes maintaining production in full cGMP compliance. Assist with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed.

• Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting.

• Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment.

• Ensure all safety and compliance procedures are followed at all times.

• Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.

• Provide training to manufacturing staff on process and equipment.

• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.

• Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner.

• Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes

• Write, review & revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc)

• Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.

• Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant.

• Participate in the design, development, and implementation of processes in support of the manufacturing floor.

• Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation.

• Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek will possess these qualifications.

Basic Qualifications:

High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience

OR

Associates + 2 years biotech or pharmaceutical manufacturing, process development or quality experience

OR

Bachelors + 6 months biotech or pharmaceutical manufacturing, process development or quality experience work experience

OR

Master's

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences

• Technical understanding of pharmaceutical/biotech packaging equipment and processes

• Experience with Current Good Manufacturing Practices (cGMP)

• Ability to be flexible and manage change

• Experience participating in and leading cross-functional teams

• Experience in managing multiple, competing priorities in a fast-paced environment

• Strong scientific, technical interactions with partner organizations such as PD and F&E.

• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.

• Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification

• Ability to organize, analyze, and interpret technical data that is impacting operations

• Background in lean manufacturing methodologies and operational excellence

• Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.)

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.

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.