Process Development and Quality Engineering Manager

Job Description

Drive innovation and quality at the intersection of science and technology. As Process Development and Quality Engineering Manager at Agilent’s Carpinteria site, you will lead a talented team of scientists and engineers supporting our Diagnostics and Genomics Group (DGG) – Pathology Products. You’ll play a critical role in ensuring manufacturing readiness, regulatory compliance, and continuous improvement across our immunohistochemistry (IHC) cancer diagnostics portfolio. This hybrid leadership role offers the opportunity to shape operational strategy, modernize lab technologies, and deliver meaningful impact across the product lifecycle.

Key Responsibilities

• Lead and mentor a cross-functional team in process development, new product introduction (NPI), and lifecycle support for commercial manufacturing.

• Oversee NPI and product transfer activities to ensure process robustness, manufacturability, and compliance.

• Define and implement validation strategies for processes, methods, software, and equipment in alignment with FDA QSR, ISO 13485, and internal policies.

• Introduce and scale digital lab technologies and automation to enhance manufacturing and development efficiency.

• Leverage Lean and Six Sigma methodologies to drive continuous improvement across products, processes, and equipment.

• Optimize enterprise systems such as Agile PLM, SAP, LIMS, and MES to support data integrity, compliance, and scalability.

• Collaborate closely with R&D, Quality, Manufacturing, and Regulatory Affairs to deliver high-quality products on schedule.

• Contribute to long-term operational strategy focused on cost savings, quality enhancements, and sustainable growth.

Qualifications

• Bachelor’s or advanced degree in Engineering, Chemistry, Life Sciences, or a related field

• 8+ years of experience in regulated life sciences, diagnostics, or medical device manufacturing

• 1+ years of leadership experience managing technical or cross-functional teams

• Strong knowledge of validation practices across processes, methods, software, and equipment

• Experience with lab automation, digital tools, and process performance monitoring

• Proficiency with FDA QSR, ISO 13485, and related regulatory standards

• Working knowledge of Agile PLM, SAP, LIMS, and MES

Preferred:

• Experience in pathology products, especially immunohistochemistry (IHC)

• Lean Six Sigma certification (Green or Black Belt)

• Strong communication, collaboration, and change management skills

• Strategic mindset with a focus on scalable, sustainable innovation

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least June 3, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $132,851.00 - $207,580.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

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 [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory