7 days old

Sr Validation Scientist

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    122004787
Amgen

Job ID: R-101765
Location: Juncos, PR, US 00777

Are you looking for a challenging new opportunity to test and growth your validation skills? We have an immediate need for a Sr Validation Scientist to join AML-14 Drug Product team. This is an outstanding 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:

Independently provides and/or advises the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies sophisticated and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, coordinates, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.

Complete sophisticated or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.

Employ sophisticated validation engineering techniques and/or modifications of sophisticated techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.

Develop technical solutions to complex problems requiring the regular use of resourcefulness and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly sophisticated process, system/facility modifications.

Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Timely and regular attendance to the workplace.
  • Other functions may be assigned


Knowledge:

  • Advance knowledge in Aseptic Processing, Media Fill, Environmental Monitoring Qualification and Air Visualization Studies.
  • Sophisticated validation knowledge (equipment qualification, cleaning, sterilization).
  • Applies extensive technical validation expertise and has full knowledge of other related disciplines.


Problem Solving:

  • Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, detailed, practicable, and consistent with organization objectives.


Discretion/Latitude:

  • Exercises considerable latitude in resolving technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
  • Supervision and mentorship relate largely to overall objectives, critical issues, new concepts, and policy matters.


Impact:

  • Crucial to the completion of broad programs and projects.
  • Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.


Leadership:

  • Leads efforts of group of peers directly supervises staff or project resources.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • May be encouraged to directly supervise staff or project resources.


Liaison:

  • Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.


Regulatory:

  • Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
  • Represents the organization as the technical specialist to endorse the organization's validation programs and practices


Education/licenses:

Doctorate degree

or

Master's degree and 3 years of validation and/or scientific experience in GMP regulated industry

or

Bachelor's degree and 5 years of validation and/or scientific experience in GMP regulated industry

Competencies/skills:

  • In-depth knowledge of validation processes and requirements
  • Interacts optimal with variety of communication and working styles
  • Ability to independently resolve when additional internal resources are required to tackle problems
  • Ability to prioritize different projects at one time
  • Proven Skills in the following areas:
  • Schedule development
  • Facilitation
  • Collaboration
  • Basic project management
  • Completion and follow-up:
  • Technical expertise areas of validation engineering.
  • Ability to independently resolve when additional external resources are required to tackle problems
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Solid understanding of financial analysis tools
  • Ability to delegate and lead the project work of others


Proven Skills in the following areas:

  • Negotiation, persuasion and facilitation
  • Collaboration
  • Project cost development
  • Conflict Resolution
  • Decision Making
  • Leadership and teambuilding
  • Management of contractors and vendors


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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.



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Posted: 2020-07-29 Expires: 2020-08-29

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Sr Validation Scientist

Amgen
Juncos, Puerto Rico 00777

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