Regulatory Affairs jobs in United States

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Act as the primary interface between project stakeholders and equipment end-users.

Gather comprehensive machine specifications including:

Technical details, ESH (Environmental, Safety & Health) requirements (internal and regulatory), equipment footprint, and process needs.

Utilities and environmental specifications: CDA, vacuum, power supply, weight, vibration, DI water specs, waste disposal, noise levels, temperature/humidity control, etc.

1. Equipment End-User Coordination

• Act as the primary interface between project stakeholders and equipment end-users.

• Gather comprehensive machine specifications including:

  • Technical details, ESH (Environmental, Safety & Health) requirements (internal and regulatory), equipment footprint, and process needs.

  • Utilities and environmental specifications: CDA, vacuum, power supply, weight, vibration, DI water specs, waste disposal, noise levels, temperature/humidity control, etc.

• Coordinate with relevant departments:

  • Civil/Structural, Mechanical HVAC, Electrical, WWTP, and ESH to align infrastructure readiness.

  • IT Department to determine network, hardware, and system specifications.

  • Liaise with IT for compliance with both internal standards and local regulatory requirements.

• Collaborate with Industrial Engineering (IE) and Draughtsman to:

  • Develop final equipment layout based on confirmed equipment footprint and agreed location.

  • Present proposed layouts to stakeholders for approval during weekly project meetings.

• Partner with Facilities Operation, ESH, and IT teams to:

  • Develop Bill of Quantities (BOQ) and prepare documentation for tender processes.

• Engage with the project owner to:

  • Align on financing, budgeting, internal orders (IO), and timelines leading to production release.

  • Prepare cost proposals in collaboration with Facilities Operations, ESH, and IT.

• Coordinate with area owners and IE to:

  • Define and clear project zones, ensuring proper relocation of production assets (e.g., cabinets, trolleys, workstations) without disrupting operations.

• Align project timelines across all internal stakeholders (Facilities, ESH, Equipment Users).

• Develop a comprehensive Gantt chart including:

  • Civil/structural works, mechanical HVAC, electrical, WWTP, ESH, and IT tasks.

• Initiate and follow up with local authorities (e.g., Bomba, TNB, SAINS, MBS) on compliance approvals such as:

  • Certificate of Completion and Compliance (CCC) and other permits.

• Track delivery schedules and monitor adherence to the Gantt chart.

• Compile and present readiness reports during project meetings.

• Identify deviations (e.g., variation orders, schedule delays) and escalate to management for approval in a timely manner.

• Oversee equipment delivery, testing, and commissioning.

• Ensure smooth verification and handover involving Facilities, ESH, IT, IE, and machine users.

• Maintain comprehensive records of project documents including:

  • Drawings, RFIs, VO requests, commissioning reports, buy-off documentation, and local authority approvals.

  Requirements

• Bachelor degree in Mechanical/ Electrical

• Minimum 5 years experience in clean room/ semiconductor facilities environment.

• Well verse in local safety regulation i.e: Bomba, DOSH, DOE.

• Sound knowledge and practical in project planning, scheduling, resource allocation, and risk management.

• Strong communication, leadership, and the ability to manage complex, often high-pressure projects.

• Certification in energy management, WWTP, electrical wireman/ chargeman will be an added value.

Salary match Number of applicants Skills match

Your application will include the following questions:

Which of the following statements best describes your right to work in Malaysia? What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a project engineer?

Consumer Electronics Manufacturing 1,001-5,000 employees

Nexperia is a world-class company in semiconductor development and in-house production. A proven global player with an entrepreneurial mentality. At our core is an 11,000+ strong international network with a singular focus. Built on passion and commitment to our work, belief in our goals and a drive to succeed regardless of the challenges we face. We support, reward and challenge individuals equally, in a dynamic and energetic environment.

Looking to push boundaries in a company where your talents can shine? Join TeamNexperia.

"Nexperia shall not engage in discrimination based on race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, political affiliation, covered veteran status, protected genetic information or marital status in hiring."

Nexperia is a world-class company in semiconductor development and in-house production. A proven global player with an entrepreneurial mentality. At our core is an 11,000+ strong international network with a singular focus. Built on passion and commitment to our work, belief in our goals and a drive to succeed regardless of the challenges we face. We support, reward and challenge individuals equally, in a dynamic and energetic environment.

Looking to push boundaries in a company where your talents can shine? Join TeamNexperia.

"Nexperia shall not engage in discrimination based on race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, political affiliation, covered veteran status, protected genetic information or marital status in hiring."