26 days old

Senior Automation Engineer - AML6 Drug Substance

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    114879973
Amgen

Job ID: R-86195
Location: Juncos, PR, US 00777

Are you looking for a challenging new opportunity to test and growth your Automation Engineering skills? We have an immediate need for a Senior Automation Engineer 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.

If you're the right person for this opportunity you will have a passion for automation design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams. We seek a high technical leader, and someone comfortable within an innovative, fast paced environment.

The role

The Senior Automation Engineer is an exempt position and will apply the advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role is crucial for Amgen's success and it will be a key contributor in the AML 6 Drug Substance non-standard shift operations.

You will have a meaningful role for AML6 facility by supporting the Engineering Department and day to day operational issues in the manufacturing, pilot plant or capital projects environment.

You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or automation projects of significant scope and complexity. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.

Specific responsibilities include but are not limited to:

  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Develop engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers, 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.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Prompt and regular attendance to workplace.
  • Delegate and manage the project work of others.
  • Interacts effectively with variety of communication and working styles.
  • Independently determine when additional internal resources are needed to solve problems.
  • Handle multiple projects at one time.
  • Troubleshoot and resolve equipment, automation or process issues in the field.
  • Working closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
  • Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
  • Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
  • Design, installation, programming and validation of automated processes is essential.
  • 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. Management of contractors and vendors.
  • Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
  • Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems , Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
  • Develop of detailed specification, engineering documents, SOP and operating standards.
  • Provide solutions to a large variety of technical problems of moderate to large complexity and scope.
  • Support non-standard shift operations that may be include extended hours and/or weekends.
  • Develop solutions to routine technical problems of limited scope.


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.

Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support Amgen's mission. If you have growth mindset and you thrive under pressure, you are probably a great fit for our team!.

Basic Qualifications

Bachelor's degree in Engineering & 5 years of experience in the Medical Device, Pharmaceutical and/or Biotechnology industries.

OR

Master's degree in Engineering & 3 years of experience in the Medical Device, Pharmaceutical and/or Biotechnology industries.

OR

Doctorate degree

Beyond that, the preferred qualifications are:

  • Educational background in Computer, Electrical, Chemical and/or Mechanical Engineering
  • Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
  • Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
  • Strong process control systems automation background.
  • Experience with Tech Transfer, Process Design, and Commissioning
  • Experience with validation and change control methodology
  • Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
  • Excellent written and verbal communication skills and the ability to work with minimum direction.
  • Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment.
  • Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
  • Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture.
  • In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs
  • In-depth knowledge in programing language (e.g. VBA). In-depth knowledge of validation processes and requirements as applied to new equipment installations
  • Familiarity with OSI PI Historian.
  • Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure.
  • Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context.
  • Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
  • Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage.
  • Work schedule flexibility as required to support 24/7 operations, be able to work on non standard shifts providing engineering coverage.
  • Experienced in change control, non-conformance, corrective and preventative actions, and validation practices.
  • ISA Certified Automation Professional.
  • Working knowledge of pharmaceutical/biotech processes and process equipment.
  • Familiarity with validation processes and documentation in a highly regulated environment.
  • Ability to interpret and apply GMPs and apply engineering science to production.
  • Basic project management skills
  • Problem solving skills with the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Working knowledge of financial analysis tools.


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 health insurance benefits, performance bonus an award-winning retirement 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.

PI114879973

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86195<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>Are you looking for a challenging new opportunity to test and growth your Automation Engineering skills? We have an immediate need for a Senior Automation Engineer 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>If you're the right person for this opportunity you will have a passion for automation design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams. We seek a high technical leader, and someone comfortable within an innovative, fast paced environment.<br><br><b><b>The role</b></b><br><br>The Senior Automation Engineer is an exempt position and will apply the advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role is crucial for Amgen's success and it will be a key contributor in the AML 6 Drug Substance non-standard shift operations.<br><br>You will have a meaningful role for AML6 facility by supporting the Engineering Department and day to day operational issues in the manufacturing, pilot plant or capital projects environment.<br><br>You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or automation projects of significant scope and complexity. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.<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>Develop engineering policies and procedures that affect multiple organizational units.</li><li>Supervise, coordinate and review work of a small staff of engineers, 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>Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.</li><li>Application of mature engineering knowledge in planning and conducting projects.</li><li>Prompt and regular attendance to workplace.</li><li>Delegate and manage the project work of others.</li><li>Interacts effectively with variety of communication and working styles.</li><li>Independently determine when additional internal resources are needed to solve problems.</li><li>Handle multiple projects at one time.</li><li>Troubleshoot and resolve equipment, automation or process issues in the field.</li><li>Working closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements.</li><li>Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.</li><li>Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.</li><li>Design, installation, programming and validation of automated processes is essential.</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. Management of contractors and vendors.</li><li>Coordinate the work of consultants, architects and engineering firms on development of standard design documents.</li><li>Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.</li><li>Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.</li><li>Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems , Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).</li><li>Develop of detailed specification, engineering documents, SOP and operating standards.</li><li>Provide solutions to a large variety of technical problems of moderate to large complexity and scope.</li><li>Support non-standard shift operations that may be include extended hours and/or weekends.</li><li>Develop solutions to routine technical problems of limited scope.</li></ul><br><br><b><b>The department</b></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>Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support Amgen's mission. If you have growth mindset and you thrive under pressure, you are probably a great fit for our team!.<br><br><b><b>Basic Qualifications </b></b><br><br>Bachelor's degree in Engineering & 5 years of experience in the Medical Device, Pharmaceutical and/or Biotechnology industries.<br><br>OR<br><br>Master's degree in Engineering & 3 years of experience in the Medical Device, Pharmaceutical and/or Biotechnology industries.<br><br>OR<br><br>Doctorate degree<br><br><b><b>Beyond that, the preferred qualifications are:</b></b><br><br><ul><li>Educational background in Computer, Electrical, Chemical and/or Mechanical Engineering</li><li>Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.</li><li>Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.</li><li>Strong process control systems automation background.</li><li>Experience with Tech Transfer, Process Design, and Commissioning</li><li>Experience with validation and change control methodology</li><li>Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.</li><li>Excellent written and verbal communication skills and the ability to work with minimum direction.</li><li>Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment.</li><li>Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.</li><li>Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture.</li><li>In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs</li><li>In-depth knowledge in programing language (e.g. VBA). In-depth knowledge of validation processes and requirements as applied to new equipment installations</li><li>Familiarity with OSI PI Historian.</li><li>Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure.</li><li>Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context.</li><li>Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.</li><li>Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage.</li><li>Work schedule flexibility as required to support 24/7 operations, be able to work on non standard shifts providing engineering coverage.</li><li>Experienced in change control, non-conformance, corrective and preventative actions, and validation practices.</li><li>ISA Certified Automation Professional.</li><li>Working knowledge of pharmaceutical/biotech processes and process equipment.</li><li>Familiarity with validation processes and documentation in a highly regulated environment.</li><li>Ability to interpret and apply GMPs and apply engineering science to production.</li><li>Basic project management skills</li><li>Problem solving skills with the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.</li><li>Working knowledge of financial analysis tools.</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 health insurance benefits, performance bonus an award-winning retirement 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/PdRlBKFQZR5bTMNmTPXLW"> <p>PI114879973</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Senior Automation Engineer - AML6 Drug Substance

Amgen
Juncos, Puerto Rico 00777

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