Process Reliability Engineer

Reposted 15 Days Ago
Be an Early Applicant
Penang, Daerah Timor Laut, Penang, MYS
In-Office
5-5 Annually
Senior level
Biotech
The Role
The Operations Excellence Engineer will lead continuous improvement initiatives, enhance operational efficiency, and manage cost optimization projects across various departments.
Summary Generated by Built In
Job Description

A Process Reliability Engineer ensures that manufacturing processes are robust, reliable, and compliant with applicable ISO standards, regulatory requirements, and internal quality systems. The role involves analyzing field and customer data, executing incoming, in‑process, and outgoing quality checks, and supporting reliability testing and environmental qualification to ensure product reliability throughout the lifecycle.

Principal Duties and Responsibilities
Develop, review, and revise manufacturing processes and process‑reliability–related procedures.

Ensure effective implementation, control, and maintenance of records related to engineering changes, process qualifications, investigations, and corrective and preventive actions for process and reliability matters.

Cross‑Functional Collaboration
Partner closely with manufacturing, R&D, field operations, marketing, and global quality teams to ensure timely execution of changes, new product introduction and process risk reduction (PFMEA)

Field and Customer Quality Support
Monitor, track, and provide timely updates on assigned field and customer feedback and quality issues (e.g., defect on arrival).
Drive part return analysis, investigations, root cause analysis (RCA), and corrective and preventive actions to ensure effective and sustainable issue closure.

Data Collection and Analysis
Collect and analyze quality and reliability data using appropriate statistical and analytical tools to support quality improvement initiatives and risk mitigation.

Continuous Improvement
Identify opportunities for process and reliability improvements, recommend corrective actions, and oversee their effective implementation.

Process Validation, Reliability & Qualification
Apply strong knowledge of process validation, instrument qualification, and reliability testing methodologies to support product quality and compliance.
Review manufacturing part qualification risk assessment and test plan development related to Safety, EMC, and Environment/Stress Testing requirements.

Training and Knowledge Sharing
Participate in process and reliability quality training programs by developing, updating, and delivering training materials for new and existing employees. May mentor junior engineers and QC staff.

Audit and Regulatory Support
Act as Process Subject Matter Expert (SME) or provide backroom support during internal and external quality audits led by the Quality Assurance team.

Qualifications
  • Educational Background: A Bachelor’s or Master’s Degree, or an equivalent university qualification.
  • Experience Requirement: A minimum of 5 years of relevant professional experience.
  • Knowledge of Quality Standards: Familiarity with Quality System Standards such as ISO 9001:2015, ISO 13485:2016, FDA CFR 21 Part 820, IEC 61010, ISO17025:2025 as well as regulations related to In Vitro Diagnostics (IVD) and Medical Devices in the EU/US; familiarity with EMC and CSA safety compliance is an added advantage.
  • Data Analysis Skills: Proficient in data analysis, statistical tools, manufacturing reliability engineering, and process validation (IQ/OQ/PQ), with strong capability in root cause analysis, problem-solving, and continuous improvement (CI).
  • Language Proficiency: Fluent in English, with strong writing and verbal communication skills.

Additional Details

This job has a full time weekly schedule.

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 opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: NoShift: DayDuration: No End DateJob Function: Manufacturing

Skills Required

  • Bachelor's Degree in Engineering or Operations Management
  • At least 5 years' experience in lean manufacturing
  • Knowledge of Lean or continuous improvement methodologies
  • Strong analytical and problem-solving skills
  • Excellent communication and stakeholder management abilities
  • Proven project management experience
  • Proficiency in data analysis and reporting tools

Agilent Technologies Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Agilent Technologies and has not been reviewed or approved by Agilent Technologies.

  • Retirement Support The core U.S. package highlights a generous 401(k) match as a strength. Retirement programs are positioned as competitive within the company’s total rewards.
  • Equity Value & Accessibility An Employee Stock Purchase Plan at a discount provides accessible equity and augments total compensation. Ownership opportunities are presented as a notable advantage alongside retirement benefits.
  • Leave & Time Off Breadth Flexible Time Off, company holidays, a personal holiday, and paid volunteer time create a broad leave offering. Time off can accrue into multiple weeks in the first year, supporting flexibility.

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The Company
HQ: Santa Clara, CA
17,369 Employees
Year Founded: 1999

What We Do

Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.

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