Facilities Engineer

4 weeks ago


Woodstock, Canada Automated Systems, Inc. Full time

Contract to Hire | Automated Systems, Inc. | United States

Posted On 02/24/2025

Job Information

Pharma/Biotech/Clinical Research

$35-50/hr

State/Province

Illinois

City

Woodstock

60098

Job Description

FT – ONSITE – Contract to Hire

Sponsorship is not available for this role

The Facilities Engineer provides critical engineering support for GMP manufacturing utilities. This role collaborates closely with Facilities, Engineering, and Manufacturing teams to design, scale-out, and improve manufacturing capabilities, supporting both existing operations and new facility development. The ideal candidate will have a strong understanding of clean utility systems and a proven track record of successful project execution within a regulated environment.

Responsibilities:

- Lead the design, implementation, and commissioning of new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing.

- Author and review protocols, standard operating procedures (SOPs), and provide technical assessment and approval for engineering and process changes.

- Collaborate with industry consultants to develop design specifications, P&ID drawings, GA drawings, User Requirements Specifications (URS), Functional Specifications (FS), and automation control strategies.

- Write and review technical documentation, including protocols and reports, for Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) testing.

- Provide technical solutions to facility and utility equipment problems, including troubleshooting and root cause analysis.

- Conduct investigations of manufacturing deviations and anomalies related to facility system failures.

- Perform utility monitoring, utility capability analysis, statistical analysis, and quality engineering activities related to facility systems.

- Manage projects within budget and timeline constraints.

- Ensure compliance with all relevant GMP regulations and industry standards.

- Stay current with industry best practices and emerging technologies in pharmaceutical manufacturing facilities engineering.

Requirements

- Bachelor’s degree in Chemical, Biochemical, Mechanical Engineering, Biotechnology, or equivalent.

- Minimum of five (5) years of related experience in pharmaceutical manufacturing facilities engineering.

- In-depth understanding and knowledge of clean utility systems, including:

- Purified water generation and distribution.

- HVAC systems for clean rooms.

- Experience with GMP regulations and validation processes (IQ/OQ/PQ).

- Proficiency in reading and interpreting P&ID drawings, GA drawings, and other technical documentation.

- Strong project management skills and ability to manage multiple projects simultaneously.

- Excellent problem-solving and analytical skills.

- Strong communication and interpersonalskills, with the ability to collaborate effectively with cross-functional teams.

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