Frederick, CO, US
45 days ago
Manufacturing Operations Investigator
Job Description

At Agilent, we are driving innovation in life-changing, lifesaving medicines. Join our team in advancing the next frontier of biopharma by supporting the production of nucleic acid therapeutics. We offer an opportunity to be part of a high-performance manufacturing team dedicated to delivering perfection in our new innovative facility. Together, we’re helping craft the future of medicine.

Key Responsibilities

Lead investigations by gathering data to identify root causes, assess product/equipment impact, and develop corrective and preventive actions (CAPAs).

Author comprehensive investigation reports and revise technical documents, including facility and equipment SOPs.

Lead change controls and CAPAs to ensure compliance with quality standards.

Participate in customer and regulatory meetings, audits, and inspections, ensuring readiness and compliance.

Essential Functions

Deviation Investigation & CAPA: Conduct detailed root cause analysis, lead teams to resolve deviations, and develop effective CAPAs.

Change Control & Document Management: Write and handle change controls and update SOPs to drive continuous improvement.

Customer & Regulatory Support: Represent deviations, CAPAs, and change controls during inspections and customer meetings, ensuring timely resolution and compliance.

Qualifications

Bachelor's degree in a science-related field or equivalent experience.

1+ years of meaningful experience, ideally in a GMP manufacturing environment.

Strong understanding of GMP guidelines and international regulations for API and drug production.

Experience with root cause analysis, technical writing, and SOP development.

Proficient in Microsoft Word and other standard software applications.

Excellent communication and leadership skills, with the ability to run cross-functional teams and sophisticated projects.

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 email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range$70,720.00-$110,500.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Travel RequiredNo

ScheduleSchedule:Full time

ShiftDay

DurationNo End Date

Job FunctionQuality/Regulatory
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