18 days old

Associate Engineer - AML6 System Owners

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    115029662
Amgen

Job ID: R-87131
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 two Associate Engineers to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The role

Under close supervision, the Associate Engineer will assist with or directly provides technical engineering support in process optimization strategies, upgrades, replacements, and modifications in the operations, manufacturing or pilot plant environment. Ensures that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.

Employs technical knowledge of more than one area of engineering (process, unit operations, equipment project, facilities, utilities and/or daily operations) in process characterization, optimization, scale-up, or manufacturing support projects

The department

The AML-6 Facility is the home of best-in-class, 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 high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian Drug Substance manufacturing facility in the world.

As part of a non-standard shift, the team focuses on planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes.

Specific responsibilities include but are not limited to:

  • Support non-standard shift manufacturing operations that may include weekends and nights work schedule.
  • Perform standard engineering work requiring application of standard techniques and procedures.
  • Complete routine technical tasks.
  • Monitor the unit operations or system and actively assist the organization, maintenance or projects on a daily basis, as needed.
  • Routinely audit the operational performance and regulatory compliance of a limited number of equipment items or systems of minor to moderate complexity.
  • Routinely troubleshoot operational issues with individual equipment or skids.
  • Assist with the proposal, initiation, testing and implementation of proposed changes to process, utility and/or facility systems.
  • Assist more senior engineers in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
  • Support non-standard shift organization and extended hours, as per business needs.


Basic Qualifications - skills and education

Bachelor's degree in Engineering earned by January 2020

Beyond that, the preferred qualifications are:

  • Educational background in Mechanical, Electrical, Chemical, Biomedical, and/or Industrial Engineering
  • Minimal years of experience in operations/manufacturing environment
  • Exposure to or direct experience with regulated environments (i.e. cGMP, OSHA, EPA)
  • Working knowledge of pharmaceutical/biotech processes
  • Familiarity with validation processes
  • Familiarity with documentation in a highly regulated environment
  • Ability to operate specialized laboratory equipment and computers as appropriate
  • Ability to interpret and apply GLPs and GMPs
  • Ability to apply engineering science to production
  • Able to develop solutions to routine technical problems of limited scope
  • Skills in the following areas:
  • Problem solving and applied engineering
  • Basic technical report writing
  • Verbal 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.

PI115029662

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87131<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 two Associate Engineers to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.<br><br><b>The role</b><br><br>Under close supervision, the Associate Engineer will assist with or directly provides technical engineering support in process optimization strategies, upgrades, replacements, and modifications in the operations, manufacturing or pilot plant environment. Ensures that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.<br><br>Employs technical knowledge of more than one area of engineering (process, unit operations, equipment project, facilities, utilities and/or daily operations) in process characterization, optimization, scale-up, or manufacturing support projects<br><br><b>The department</b><br><br>The AML-6 Facility is the home of best-in-class, 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 high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian Drug Substance manufacturing facility in the world.<br><br>As part of a non-standard shift, the team focuses on planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes.<br><br><b>Specific responsibilities include but are not limited to:</b><br><br><ul><li>Support non-standard shift manufacturing operations that may include weekends and nights work schedule.</li><li>Perform standard engineering work requiring application of standard techniques and procedures.</li><li>Complete routine technical tasks.</li><li>Monitor the unit operations or system and actively assist the organization, maintenance or projects on a daily basis, as needed.</li><li>Routinely audit the operational performance and regulatory compliance of a limited number of equipment items or systems of minor to moderate complexity.</li><li>Routinely troubleshoot operational issues with individual equipment or skids.</li><li>Assist with the proposal, initiation, testing and implementation of proposed changes to process, utility and/or facility systems.</li><li>Assist more senior engineers in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.</li><li>Support non-standard shift organization and extended hours, as per business needs.</li></ul><br><br><b><b>Basic Qualifications - skills and education </b></b><br><br>Bachelor's degree in Engineering earned by January 2020<br><br><b>Beyond that, the preferred qualifications are:</b><br><br><ul><li>Educational background in Mechanical, Electrical, Chemical, Biomedical, and/or Industrial Engineering</li><li>Minimal years of experience in operations/manufacturing environment</li><li>Exposure to or direct experience with regulated environments (i.e. cGMP, OSHA, EPA)</li><li>Working knowledge of pharmaceutical/biotech processes</li><li>Familiarity with validation processes</li><li>Familiarity with documentation in a highly regulated environment</li><li>Ability to operate specialized laboratory equipment and computers as appropriate</li><li>Ability to interpret and apply GLPs and GMPs</li><li>Ability to apply engineering science to production</li><li>Able to develop solutions to routine technical problems of limited scope</li><li>Skills in the following areas:</li><li>Problem solving and applied engineering</li><li>Basic technical report writing</li><li>Verbal communication skills in English and Spanish</li></ul><br><br><b><b>The benefits</b></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/1wrQnVfGGWE8fAprUM52z"> <p>PI115029662</p>

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Posted: 2019-11-01 Expires: 2019-12-02

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Associate Engineer - AML6 System Owners

Amgen
Juncos, Puerto Rico 00777

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