12 days old

Sr Engineer - Process Validation

Amgen
West Greenwich, RI 02817
  • Job Code
    119148816
  • Jobs Rated
    8th
Amgen

Job ID: R-91634
Location: West Greenwich, RI, US 02817

Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Do you want to work with a highly motivated team of process science professionals to positively impact patients' lives?

We have a position available for a Senior Engineer to join the process validation team at our Rhode Island Facility. You will join a team focused on leading the execution of Process Validation programs for existing and new product introductions. The site operates two multiproduct facilities that manufacture a range innovative biologic and biosimilar medicines. The role requires strong subject matter expertise in the development and execution of process validation programs, including the development and execution of Masterplans, protocols and summary reports. An ability to design a robust validation program and to troubleshoot systematic validation issues is an essential requirement of the role. The role is responsible for ensuring Process Validation activities are performed in a consistent and controlled manner to support the manufacture of Drug Substance.

Responsibilities include:
  • Lead Process Validation project activities at ARI
  • Provide leadership and coordination of process validation activities with site partners
  • Support the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards
  • Lead the execution of validation projects and/or protocols and the collection of data to support completion of Process Validation activities
  • Review requirements and source process design and execution documentation for use in development of process validation documents
  • Develop/Update appropriate Validation Master Plans
  • Develop and author Validation protocols/reports
  • Author validation sections for Regulatory filings and/or provide data verification
  • Provide guidance for the generation, resolution and closure of deviations
  • Provide Process Validation oversight as part of the Change Control process.
  • Participate in internal company and external health authority audits
  • Develop and mentor junior staff in validation activities
  • Champion Operational Excellence Projects
  • Keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.


This role provides opportunities for career development. Also, the role is a great opportunity to develop candidate's leadership, teamwork, communication skills and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems. This role will immerse the candidate in all aspects of operations in a commercial bulk drug facility.

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of operations/engineering/manufacturing/quality experience

OR

Bachelor's degree and 5 years of operations/engineering/manufacturing/quality experience

OR

Associate's degree and 10 years of operations/engineering/manufacturing/quality experience

OR

High school diploma / GED and 12 years of operations/engineering/manufacturing/quality experience

Preferred Qualifications:
  • 6 Years of experience in pharmaceutical or bio-pharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment Technical understanding of pharmaceutical/biotechnology unit operations
  • Direct Validation experience with pharmaceutical or bio-pharmaceutical processes including the development of strategies, master plans, protocols and reports
  • Proven experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or bio-pharmaceutical processes
  • Strong skills in communication, presentation, organization, team development and leadership
  • Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, bio-pharmaceutical processes, project management, strategic resource management and business analysis
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • System knowledge and experience with EBR, Delta V, Deviation, CAPA and Change Control processes
  • Knowledge and experience of the operation of Bio-pharmaceutical manufacturing processes (upstream and downstream technologies)
  • Excellent verbal and written communication skills
  • Ability to manage multiple complex tasks at one time


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.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

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.

PI119148816

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91634<br/><b>Location: </b>West Greenwich, RI, US 02817<br/><br/>Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Do you want to work with a highly motivated team of process science professionals to positively impact patients' lives?<br><br>We have a position available for a Senior Engineer to join the process validation team at our Rhode Island Facility. You will join a team focused on leading the execution of Process Validation programs for existing and new product introductions. The site operates two multiproduct facilities that manufacture a range innovative biologic and biosimilar medicines. The role requires strong subject matter expertise in the development and execution of process validation programs, including the development and execution of Masterplans, protocols and summary reports. An ability to design a robust validation program and to troubleshoot systematic validation issues is an essential requirement of the role. The role is responsible for ensuring Process Validation activities are performed in a consistent and controlled manner to support the manufacture of Drug Substance.<br><br>Responsibilities include:<br><ul><li>Lead Process Validation project activities at ARI</li><li>Provide leadership and coordination of process validation activities with site partners</li><li>Support the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards</li><li>Lead the execution of validation projects and/or protocols and the collection of data to support completion of Process Validation activities</li><li>Review requirements and source process design and execution documentation for use in development of process validation documents</li><li>Develop/Update appropriate Validation Master Plans</li><li>Develop and author Validation protocols/reports</li><li>Author validation sections for Regulatory filings and/or provide data verification</li><li>Provide guidance for the generation, resolution and closure of deviations</li><li>Provide Process Validation oversight as part of the Change Control process.</li><li>Participate in internal company and external health authority audits</li><li>Develop and mentor junior staff in validation activities</li><li>Champion Operational Excellence Projects</li><li>Keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.</li></ul><br><br>This role provides opportunities for career development. Also, the role is a great opportunity to develop candidate's leadership, teamwork, communication skills and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems. This role will immerse the candidate in all aspects of operations in a commercial bulk drug facility.<br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of operations/engineering/manufacturing/quality experience<br><br>OR<br><br>Bachelor's degree and 5 years of operations/engineering/manufacturing/quality experience<br><br>OR<br><br>Associate's degree and 10 years of operations/engineering/manufacturing/quality experience<br><br>OR<br><br>High school diploma / GED and 12 years of operations/engineering/manufacturing/quality experience<br><br><b>Preferred Qualifications:</b><br><ul><li>6 Years of experience in pharmaceutical or bio-pharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment Technical understanding of pharmaceutical/biotechnology unit operations</li><li>Direct Validation experience with pharmaceutical or bio-pharmaceutical processes including the development of strategies, master plans, protocols and reports</li><li>Proven experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or bio-pharmaceutical processes</li><li>Strong skills in communication, presentation, organization, team development and leadership</li><li>Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, bio-pharmaceutical processes, project management, strategic resource management and business analysis</li><li>Ability to evaluate compliance issues and interact with regulatory inspectors</li><li>System knowledge and experience with EBR, Delta V, Deviation, CAPA and Change Control processes</li><li>Knowledge and experience of the operation of Bio-pharmaceutical manufacturing processes (upstream and downstream technologies)</li><li>Excellent verbal and written communication skills</li><li>Ability to manage multiple complex tasks at one time</li></ul><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>About Amgen<br><br>Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.<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/RD4MAZflZljQIPbefpLBV"> <p>PI119148816</p>

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Posted: 2020-03-19 Expires: 2020-04-19

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Sr Engineer - Process Validation

Amgen
West Greenwich, RI 02817

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