Sr Validation Scientist

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 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

If you're the right person for this opportunity you will have a passion for mechanical design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams.

As Sr Validation Scientist you will have a meaningful role for AML6 facility by leading the Validation activities. In addition, you will ensure that all activities are completed on time while meeting safety, quality, and financial objectives.

You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or engineering 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.

Independently provides and/or directs the technical validation 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 advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Complete complex or novel assignments requiring development of new and/or improved process validation techniques and procedures.
• Develop process validation 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 advanced process validation techniques and/or modifications of advanced techniques within area of process validation expertise.
• Apply knowledge of process validation 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 ingenuity and creativity.
• Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
• Work with project managers to complete the process validation responsibilities of technology transfer and commercial operation projects within schedule, budget and quality constraints.
• Prompt and regular attendance to the workplace.
• Be flexible to support extended hour, non-standard shifts and manage changes.

• Applies extensive technical process validation expertise, and has full knowledge of other related disciplines.

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

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

• Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.

• Guides the successful completion of major programs and may function in a project leadership role.

• May be expected to directly supervise staff or project resources.

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

• 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 expert to endorse the organization's process validation program and practices.

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 - 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

PREFERRED QUALIFICATIONS

• Education discipline/background in Life Sciences and/or Engineering.
• Experience in process/cleaning validation execution
• Advanced validation knowledge (process, cleaning)
• Experience in validation protocol and reports generation and execution
• Understanding of the biologics drug substance manufacturing processes (cell culture/fermentation, chromatography, filtration and separation processes)
• Experience in evaluation for validation deviations impacts
• In-depth knowledge and experience of process validation processes and requirements.
• Fully bilingual (English/Spanish).
• Advanced scientific analysis, troubleshooting and laboratory work skills.

• Interacts effectively with variety of communication and working styles.
• Ability to handle multiple projects at one time.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Skills in the following areas:
  • Schedule development
  • Facilitation
  • Collaboration
  • Basic project management
  • Completion and follow-up
  • Negotiation, persuasion and facilitation
  • Collaboration
  • Project cost development
  • Conflict Resolution
  • Decision Making
  • Leadership and team-building
  • Management of contractors and vendors

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.