Plant Engineer

Overview

Oversee facility plant systems, ensure compliance, manage maintenance in pharma.

Key Responsibilities

• equipment qualification
• lifecycle management
• preventive maintenance
• facility operations
• regulatory compliance
• vendor coordination

Tasks

-Plan and coordinate equipment IQ, OQ, and PQ activities. -Oversee the full lifecycle of critical equipment from installation to decommissioning. -Develop and maintain preventive maintenance and calibration schedules for facility and production equipment. -Oversee the day-to-day management of the facility’s physical plant and critical systems, including electrical distribution, HVAC, cleanroom environmental controls, EMS, BMS, and security systems. -Ensure strict compliance with FDA regulations, cGMP, and USP 797/800 guidelines. -Coordinate with external vendors for facility services, repairs, and equipment calibration. -Act as the facility subject matter expert during internal audits and external regulatory inspections. -Manage building utilities and site infrastructure to ensure uninterrupted support for production operations.

Requirements

• cleanroom ops
• equipment qualification
• fda compliance
• project management
• bs engineering
• 5+ years

What You Bring

-In-depth knowledge of cleanroom operations and environmental control systems. -Familiarity with equipment qualification and validation processes. -Experience in training or guiding technicians/staff. -Strong understanding of FDA regulatory requirements and industry standards. -Proven track record of managing facility systems in a regulated manufacturing environment. -Demonstrated ability to scale operations and implement new technologies or systems. -Must have 5 employees to enroll in benefits; coming soon! -Experience leading facility expansion projects and cleanroom construction/upgrades. -Excellent project management and organizational skills. -Effective communication and leadership abilities. -Experience with quality systems documentation and change control procedures. -Minimum BS degree in Engineering or related field. -5+ years of facilities or engineering operations management experience in a pharmaceutical, biotechnology, or 503B sterile compounding facility under cGMP conditions.

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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