Design Control Specialist, Intermediate

Job Description


Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at

Job Function

This position is in Agilent's Companion Diagnostics (CDx) division and supports development of precision medicine diagnostic devices for oncology therapies. The Design Control Specialist will work closely and collaboratively with specialists in R&D, project management, clinical affairs, regulatory affairs, manufacturing and quality assurance teams to guide the development of high-quality companion diagnostic products by planning and executing design control processes and strategies as part of our Quality Management System.

Innovative ideas and excellent performance will bring value for Agilent and contribute to treating cancer. Often entails problem solving the best way to document design controls for new projects with unique challenges.

a) Organizational

Position has no reporting employees and reports to one direct manager.

b) Span of Control and Authority

Position requires the authority to draft documents, initiate workflows in Agile, and make changes necessary to support product development within the CDx R&D department.

c) Communication / Contacts

Internal:
Communicate with project managers, scientists, research associates within R&D and representatives from other departments (e.g. production, RA, QA, etc.) as required to aid in development of various CDx products.

External:
No planned communication with external contacts (i.e. vendors, customers, etc.); however, communication with representatives from these groups may occur. For example, employee may be required to interacts with auditors performing facility and process inspections, or to present a brief update to a pharma partner in a Joint Project Team meeting.

Job Responsibilities

• Ensuring the successful design and development of new products through collaboration with cross-functional teams
• Supporting development of design control records including design and development planning, risk management files, Verification & Validation (V&V) plans, requirement traceability matrices, etc.
• Maintaining Design & Development File (DDF) and ensuring its accuracy
• Coordinating and leading design review meetings and design changes
• Contributing to and maintaining the risk management file with input from development teams
• Identifying and implementing process improvements to establish standardized best practices
• Working across Agilent divisions to draft and provide input to Agilent global documentation and processes
• Supporting and contributing to internal and external audits
• Working on problems of diverse scope, ensuring alignment and consistency wherever possible
• Exercising judgment within generally defined practices and policies to problem-solve when faced with complex challenges

This can be a remote position- it does require on-site presence for certain tasks


Qualifications


1. Education

• Bachelor's degree (BS) or advanced degree in biological sciences

2. Experience

• Minimum 3+ years relevant experience (product development/assay development/IHC/ISH)

Required Skills:

• Strong writing skills
• High attention to detail
• Presentation skills (internal and external)
• Excellent communication and teamwork
• Ability to work independently

Preferred:

• Understanding of design control regulations and documentation requirements
• Knowledge in:
  • Immunohistochemistry
  • In situ hybridization
  • Cell biology
  • Molecular biology
• Experience in the diagnostics industry

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact  email  EOE AA M/F/Vet/Disability/Sexual Orientation/Gender Identity.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Additional Details

This job has a full time…