24 days old

Associate Manufacturing - AML7 Drug Substance

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    115601478
Amgen

Job ID: R-87555
Location: Juncos, PR, US 00777

Amgen is looking for creative and hardworking professional to join AML7-Drug Substance team as Associate Manufacturing.

The role

This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Microbial facility. After the completion of the onboarding and applicable training qualifications; you will set about preparing and operating operation-critical equipment.

To keep everything running smoothly, you will also be involved in monitoring, sampling and testing, use pumps, sterile tube welders and aseptic connectors - and document procedures and results. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft ever-more efficient methods and processes around the facility.

Time spent in a classified room performing and monitoring critical processes or executing testing on the floor such as pH, conductivity; hands on experience with SAP, EBR and Equipment Interphase (HMIs) systems and equipment preparations (CIP/PT/SP) would help. But if you are driven, enjoy taking on new challenges, love to work in teams and are a confident communicator, you will thrive here.

The department

The AML-7 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.

As part of a non-standard rotating shift, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. There will also be opportunities to take on Fermentation and Purification activities.

As part of a non-standard shift, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. With both formal learning and on the job training, it is the perfect place to develop.

Specific responsibilities include but are not limited to:

  • Support non-standard shifts organization (first, second, third, twelve hours and/or weekend shifts), as per business needs
  • Hands-on operations, set-up, clean in place, sterilize in place and execute cell culture operations or media preparation per procedures
  • Prepare sampling equipment, analyze samples using sophisticated analytical equipment
  • Perform and monitor critical processes
  • Execute routine validation protocols
  • Follow GMP's in alignment with the compliance of the process
  • Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports)
  • Initiate Quality incidents
  • Identify and recommend improvements related to routine functions and implement after approval
  • Basic troubleshooting
  • Recognize & accurately report problems
  • Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
  • Interact directly with the Quality Unit
  • May train staff to perform hands-on tasks, act as safety representative, assist with system ownership responsibilities and interact with Process Development and Process Owner teams
  • Receive, store, dispense, deliver, transfer, reconcile, cycle count, or ship materials per cGMP procedures and regulations, within multiple systems and/or between multiple AML buildings
  • Ability to operate efficiently and effectively within multiple inventory software applications and resolve basic system issues within Amgen's SAP and MES system
  • Ability to safely handle, transport and manage hazardous materials
  • Ability to operate warehouse equipment, e.g. pallet jack, etc.
  • Strong customer service skills and ability to prioritize, schedule and coordinate work to meet deadlines
  • Adhere to DOT and Amgen policies and regulations, and others as required
  • May serve as a point of contact to internal and some external customers for daily operational matters
  • Strong multi-tasking skills
  • Maintain clean and safe work environment
  • Prepare for regulatory inspections and audits
  • Identify and report operational issues and process improvement opportunities to leadership and propose solutions and assist in addressing.
  • The physical demands described here are representative of those that must be met by a staff member to successfully perform the essential functions of the job:
  • Standing, walking or moving around offices, work site or Amgen buildings
  • Climbing, crawling, crouching, or other non-sitting working positions
  • Lifting, carrying, pushing, pulling objects heavy objects with appropriate industrial equipment
  • Temperature extremes (i.e.: cold rooms) or wetness, fumes, vibrations, dust
  • Exposure to noise, odors, dust, etc. of such severity as to require the use of protective equipment and/or strict work guidelines


Basic skills and education

Bachelor's degree

Beyond that, the preferred qualifications are:

  • Educational background in Life/Natural Science and/or Engineering
  • Minimal work experience in a manufacturing GMP regulated environment
  • Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
  • Intermediate Mathematics and problem-solving skills.
  • Proficient performing assembling disassembling, operating and understanding equipment per procedures.
  • Knowledge with basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
  • Ability and willingness to work any shift in support of operations that may include 24/7.
  • Organization skills and talent to perform assignments with a high degree of attention to detail.
  • Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.
  • Good documentation skills.
  • Written and oral communication skills in English and Spanish.


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

PI115601478

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87555<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>Amgen is looking for creative and hardworking professional to join AML7-Drug Substance team as Associate Manufacturing.<br><br><b>The role</b><br><br>This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Microbial facility. After the completion of the onboarding and applicable training qualifications; you will set about preparing and operating operation-critical equipment.<br><br>To keep everything running smoothly, you will also be involved in monitoring, sampling and testing, use pumps, sterile tube welders and aseptic connectors - and document procedures and results. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft ever-more efficient methods and processes around the facility.<br><br>Time spent in a classified room performing and monitoring critical processes or executing testing on the floor such as pH, conductivity; hands on experience with SAP, EBR and Equipment Interphase (HMIs) systems and equipment preparations (CIP/PT/SP) would help. But if you are driven, enjoy taking on new challenges, love to work in teams and are a confident communicator, you will thrive here.<br><br><b>The department</b><br><br>The AML-7 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.<br><br>As part of a non-standard rotating shift, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. There will also be opportunities to take on Fermentation and Purification activities.<br><br>As part of a non-standard shift, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. With both formal learning and on the job training, it is the perfect place to develop.<br><br><b>Specific responsibilities include but are not limited to:</b><br><br><ul><li>Support non-standard shifts organization (first, second, third, twelve hours and/or weekend shifts), as per business needs</li><li>Hands-on operations, set-up, clean in place, sterilize in place and execute cell culture operations or media preparation per procedures</li><li>Prepare sampling equipment, analyze samples using sophisticated analytical equipment</li><li>Perform and monitor critical processes</li><li>Execute routine validation protocols</li><li>Follow GMP's in alignment with the compliance of the process</li><li>Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports)</li><li>Initiate Quality incidents</li><li>Identify and recommend improvements related to routine functions and implement after approval</li><li>Basic troubleshooting</li><li>Recognize & accurately report problems</li><li>Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)</li><li>Interact directly with the Quality Unit</li><li>May train staff to perform hands-on tasks, act as safety representative, assist with system ownership responsibilities and interact with Process Development and Process Owner teams</li></ul><ul><li>Receive, store, dispense, deliver, transfer, reconcile, cycle count, or ship materials per cGMP procedures and regulations, within multiple systems and/or between multiple AML buildings</li><li>Ability to operate efficiently and effectively within multiple inventory software applications and resolve basic system issues within Amgen's SAP and MES system</li></ul><ul><li>Ability to safely handle, transport and manage hazardous materials</li><li>Ability to operate warehouse equipment, e.g. pallet jack, etc.</li><li>Strong customer service skills and ability to prioritize, schedule and coordinate work to meet deadlines</li><li>Adhere to DOT and Amgen policies and regulations, and others as required</li><li>May serve as a point of contact to internal and some external customers for daily operational matters</li><li>Strong multi-tasking skills</li><li>Maintain clean and safe work environment</li><li>Prepare for regulatory inspections and audits </li><li>Identify and report operational issues and process improvement opportunities to leadership and propose solutions and assist in addressing.</li><li>The physical demands described here are representative of those that must be met by a staff member to successfully perform the essential functions of the job:</li><li>Standing, walking or moving around offices, work site or Amgen buildings</li><li>Climbing, crawling, crouching, or other non-sitting working positions</li><li>Lifting, carrying, pushing, pulling objects heavy objects with appropriate industrial equipment</li><li>Temperature extremes (i.e.: cold rooms) or wetness, fumes, vibrations, dust</li><li>Exposure to noise, odors, dust, etc. of such severity as to require the use of protective equipment and/or strict work guidelines</li></ul><br><br><b>Basic skills and education</b><br><br>Bachelor's degree<br><br><b>Beyond that, the preferred qualifications are:</b><br><br><ul><li>Educational background in Life/Natural Science and/or Engineering</li><li>Minimal work experience in a manufacturing GMP regulated environment</li><li>Robust knowledge and proven successful track execution of Good Manufacturing Procedures.</li><li>Intermediate Mathematics and problem-solving skills.</li><li>Proficient performing assembling disassembling, operating and understanding equipment per procedures.</li><li>Knowledge with basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).</li><li>Ability and willingness to work any shift in support of operations that may include 24/7.</li><li>Organization skills and talent to perform assignments with a high degree of attention to detail.</li><li>Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.</li><li>Good documentation skills.</li><li>Written and oral communication skills in English and Spanish.</li></ul><br><br><b>The benefits</b><br><br>Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/Z4nAw8syW28JixqmIbXn4"> <p>PI115601478</p>

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Posted: 2019-11-19 Expires: 2019-12-20

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Associate Manufacturing - AML7 Drug Substance

Amgen
Juncos, Puerto Rico 00777

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