Manufacturing Engineer (validating (IQ, OQ, PQ))
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 days ago
Vacancies:
1 Vacancy
Job Summary
Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. Project will be focused on validating (IQ OQ PQ) of equipment.
This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.
Job Responsibilities:
Expert knowledge of Installation Operational and Performance Qualification (IQ OQ PQ) of complex systems and equipment
Study time motion methods and speed involved in maintenance production and other operations to establish standard production rate and improve efficiency.
Interpret engineering drawings schematic diagrams or formulas and confer with management or engineering staff to determine quality and reliability standards.
Read worker logs product processing sheets and specification sheets to verify that records adhere to quality assurance specifications.
Aid in planning work assignments in accordance with worker performance machine capacity production schedules and anticipated delays.
Prepare charts graphs and diagrams to illustrate workflow routing floor layouts material handling and machine utilization.
Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
Evaluate data and write reports to validate or indicate deviations from existing standards.
Skills:
Creativity verbal and written communication skills analytical and problem solving ability.
Team player and detail oriented.
Ability to make sketches engineering drawings and common computations.
Ability to read and interpret blueprints technical drawing schematics and computer-generated reports.
Previous experience with computer applications and software related to engineering field such as Computer Aided Design (CAD).
Must-Have Requirements:
Hands-on experience with IQ OQ and PQ execution
Experience in medical device validation
Ability to clearly explain validation concepts (IQ/OQ/PQ)
Ability to work independently with minimal ramp-up
Nice-to-Have:
Prior experience with Lifesciences or similar environments
Experience as a repeat contractor in regulated environments
Exposure to software validation within equipment systems
Soft Skills:
Strong communication skills
Ability to collaborate across teams
Comfortable in fast-paced high-priority environments
Not siloed; team-oriented approach
Top Candidate Indicators:
Can hit the ground running
Requires minimal guidance
Quickly understands project scope
Demonstrates deep validation experience
Education/Experience:
Bachelors degree in engineering required.
5-7 years experience required.
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. Project will be focused on validating (IQ OQ PQ) of equipment.
This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.
Job Responsibilities:
Expert knowledge of Installation Operational and Performance Qualification (IQ OQ PQ) of complex systems and equipment
Study time motion methods and speed involved in maintenance production and other operations to establish standard production rate and improve efficiency.
Interpret engineering drawings schematic diagrams or formulas and confer with management or engineering staff to determine quality and reliability standards.
Read worker logs product processing sheets and specification sheets to verify that records adhere to quality assurance specifications.
Aid in planning work assignments in accordance with worker performance machine capacity production schedules and anticipated delays.
Prepare charts graphs and diagrams to illustrate workflow routing floor layouts material handling and machine utilization.
Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
Evaluate data and write reports to validate or indicate deviations from existing standards.
Skills:
Creativity verbal and written communication skills analytical and problem solving ability.
Team player and detail oriented.
Ability to make sketches engineering drawings and common computations.
Ability to read and interpret blueprints technical drawing schematics and computer-generated reports.
Previous experience with computer applications and software related to engineering field such as Computer Aided Design (CAD).
Must-Have Requirements:
Hands-on experience with IQ OQ and PQ execution
Experience in medical device validation
Ability to clearly explain validation concepts (IQ/OQ/PQ)
Ability to work independently with minimal ramp-up
Nice-to-Have:
Prior experience with Lifesciences or similar environments
Experience as a repeat contractor in regulated environments
Exposure to software validation within equipment systems
Soft Skills:
Strong communication skills
Ability to collaborate across teams
Comfortable in fast-paced high-priority environments
Not siloed; team-oriented approach
Top Candidate Indicators:
Can hit the ground running
Requires minimal guidance
Quickly understands project scope
Demonstrates deep validation experience
Education/Experience:
Bachelors degree in engineering required.
5-7 years experience required.
