22 days old

PD Senior Engineer - Purification Sciences & Engineering

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    114924549
Amgen

Job ID: R-86809
Location: Juncos, PR, US 00777

Are you looking for a challenging new opportunity to test and growth your engineering skills? We have an immediate need for a top-tier Senior Engineer to join AML's Purification Sciences and Engineering Process Development team. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. You will provide cross-functional support to AML's drug substance manufacturing operations. The Purification Sciences and Engineering team collaborates and closely work with Amgen's manufacturing network to ensure innovation is incorporated into our processes and ensure product delivery. We are a highly dedicated team that utilizes our strength in protein sciences and purification downstream operations in support of our role serving patients.

The role

After completion of the on-boarding and applicable training/qualifications; you will join a team focused on purification downstream processes to support Drug Substance manufacturing operations and subsequently impact patient's lives every day. Day to day activities will include on-the-floor commercial support to the manufacturing facilities. Your primary technical areas of focus will be commercial scale expertise with protein chromatography techniques (i.e. Protein A, cation and anion exchange, mixed mode interaction, etc.) and filtration systems (i.e. tangential flow filtration) used during the manufacturing of biologically derived therapeutics. This is a phenomenal opportunity to gain a deep insight into development and optimization of processes as well as processes technology transfer activities across different Amgen sites.

In this role you will independently provide and/or direct the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. The role also include support to the execution of manufacturing/quality systems such as deviations, process validation, process monitoring, and new product introductions. Application of advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects will be performed. This role is crucial for Amgen's success and it will be a key contributor in the Process Development Drug Substance area.

Specific responsibilities include but are not limited to:

  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Supervise, coordinate and review work of a small group of engineer staff, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Prompt and regular attendance to workplace.
  • Provide solutions to a large variety of technical problems of moderate to large complexity using ingenuity and creativity.
  • Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.


Basic education and experience for this position are:

Doctorate degree in Engineering

OR

Master's degree in Engineering & 3 years of experience of Process Development and/or Technical service support in GMP regulated industry

OR

Bachelor's degree in Engineering & 5 years of experience of Process Development and/or Technical service support in GMP regulated industry


Additional preferred qualifications are:


  • Educational background in Mechanical, Chemical, and/or Biomedical Engineering.
  • Working knowledge of pharmaceutical/biotech processes.
  • Detailed technical understanding of bio-processing unit operations for downstream and purification processes.
  • Knowledge in protein chromatography mechanisms and protein filtration systems
  • Familiarity with validation and documentation processes in a highly regulated environment.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Interacts effectively with variety of communication and working styles.
  • Ability to handle multiple projects at one time
  • Skills in the development of hypotheses and approach.
  • Skills in the following areas:
    • Problem solving and applied engineering.
    • Basic technical report writing
    • Fully bilingual (Spanish and English)
    • Technical presentations
    • Personal Organization
    • Validation Protocol Writing
    • Dealing with and managing change
    • Analytical Problem Solving
    • Computer Literacy
    • Negotiation, persuasion and facilitation
    • Project cost development
    • Conflict Resolution
    • Leadership and team building
    • Schedule and resources loading development
    • Flexibility to work off-hours


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 a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance 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.

PI114924549

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86809<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>Are you looking for a challenging new opportunity to test and growth your engineering skills? We have an immediate need for a top-tier Senior Engineer to join AML's Purification Sciences and Engineering Process Development team. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. You will provide cross-functional support to AML's drug substance manufacturing operations. The Purification Sciences and Engineering team collaborates and closely work with Amgen's manufacturing network to ensure innovation is incorporated into our processes and ensure product delivery. We are a highly dedicated team that utilizes our strength in protein sciences and purification downstream operations in support of our role serving patients.<br><br><b>The role</b><br><br>After completion of the on-boarding and applicable training/qualifications; you will join a team focused on purification downstream processes to support Drug Substance manufacturing operations and subsequently impact patient's lives every day. Day to day activities will include on-the-floor commercial support to the manufacturing facilities. Your primary technical areas of focus will be commercial scale expertise with protein chromatography techniques (i.e. Protein A, cation and anion exchange, mixed mode interaction, etc.) and filtration systems (i.e. tangential flow filtration) used during the manufacturing of biologically derived therapeutics. This is a phenomenal opportunity to gain a deep insight into development and optimization of processes as well as processes technology transfer activities across different Amgen sites.<br><br>In this role you will independently provide and/or direct the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. The role also include support to the execution of manufacturing/quality systems such as deviations, process validation, process monitoring, and new product introductions. Application of advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects will be performed. This role is crucial for Amgen's success and it will be a key contributor in the Process Development Drug Substance area.<br><br><b>Specific responsibilities include but are not limited to:</b><br><br><ul><li>Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.</li><li>Supervise, coordinate and review work of a small group of engineer staff, associates and/or technicians on an ongoing basis as well as on a project basis.</li><li>Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.</li><li>Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.</li><li>Application of mature engineering knowledge in planning and conducting projects.</li><li>Prompt and regular attendance to workplace.</li><li>Provide solutions to a large variety of technical problems of moderate to large complexity using ingenuity and creativity.</li><li>Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.</li><li>Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.</li></ul><br><br><b>Basic education and experience for this position are:</b><br><br>Doctorate degree in Engineering<br><br>OR<br><br>Master's degree in Engineering & 3 years of experience of Process Development and/or Technical service support in GMP regulated industry<br><br>OR<br><br>Bachelor's degree in Engineering & 5 years of experience of Process Development and/or Technical service support in GMP regulated industry<br><br><b><br>Additional preferred qualifications are:</b><br><br><ul><li>Educational background in Mechanical, Chemical, and/or Biomedical Engineering.</li><li>Working knowledge of pharmaceutical/biotech processes.</li><li>Detailed technical understanding of bio-processing unit operations for downstream and purification processes.</li><li>Knowledge in protein chromatography mechanisms and protein filtration systems</li><li>Familiarity with validation and documentation processes in a highly regulated environment.</li><li>Ability to interpret and apply GLPs and GMPs.</li><li>Ability to apply engineering science to production.</li><li>Interacts effectively with variety of communication and working styles.</li><li>Ability to handle multiple projects at one time</li><li>Skills in the development of hypotheses and approach.</li><li>Skills in the following areas:<ul><li>Problem solving and applied engineering.</li><li>Basic technical report writing</li><li>Fully bilingual (Spanish and English)</li><li>Technical presentations</li><li>Personal Organization</li><li>Validation Protocol Writing</li><li>Dealing with and managing change</li><li>Analytical Problem Solving</li><li>Computer Literacy</li><li>Negotiation, persuasion and facilitation</li><li>Project cost development</li><li>Conflict Resolution</li><li>Leadership and team building</li><li>Schedule and resources loading development</li><li>Flexibility to work off-hours</li></ul></li></ul><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 a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance 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/LYWrlgSqj4d8TB74iq27g"> <p>PI114924549</p>

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Posted: 2019-10-29 Expires: 2019-11-29

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PD Senior Engineer - Purification Sciences & Engineering

Amgen
Juncos, Puerto Rico 00777

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