What are the responsibilities and job description for the Facilities Engineer position at System One?
Job Title: Facilities Engineer
Location: Malvern, PA
Type: Direct Hire
Schedule: Monday- Friday 8am to 5pm
Pay: 100K-140K
Overview:
Are you ready to take the next step in your career? This Facilities Engineer role offers a clear path to management and leadership opportunities, making it ideal for ambitious professionals eager to grow. You will play a pivotal role in supporting and optimizing facilities for GMP and API manufacturing, ensuring seamless operations in a highly regulated environment. Working closely with the Head of Facilities, you’ll lead initiatives in processing, engineering, design, project coordination, start-up, and validation of GMP and non-GMP systems. Your contributions will help shape the future of our operations while upholding the highest standards of quality and compliance.
Responsibilities
Requirements
#M3
Location: Malvern, PA
Type: Direct Hire
Schedule: Monday- Friday 8am to 5pm
Pay: 100K-140K
Overview:
Are you ready to take the next step in your career? This Facilities Engineer role offers a clear path to management and leadership opportunities, making it ideal for ambitious professionals eager to grow. You will play a pivotal role in supporting and optimizing facilities for GMP and API manufacturing, ensuring seamless operations in a highly regulated environment. Working closely with the Head of Facilities, you’ll lead initiatives in processing, engineering, design, project coordination, start-up, and validation of GMP and non-GMP systems. Your contributions will help shape the future of our operations while upholding the highest standards of quality and compliance.
Responsibilities
- Coordinate and oversee the design, installation, and maintenance of GMP-critical utilities, including purified water systems, clean steam systems, HVAC systems, and compressed air systems.
- Troubleshoot and resolve issues with facility systems to minimize downtime and ensure compliance with GMP standards.
- Support validation activities for facilities, utilities, and equipment, including authoring, reviewing, and executing validation protocols (IQ, OQ, PQ).
- Develop and maintain preventive maintenance programs for GMP and non-GMP utilities and systems.
- Conduct facility assessments to identify and implement energy efficiency and sustainability improvements.
- Ensure compliance with environmental, health, and safety (EHS) regulations in all facility operations.
- Act as a technical liaison between manufacturing, engineering, and quality teams to ensure seamless operations.
- Manage and oversee external vendors and contractors performing facility-related work, ensuring adherence to company standards and cGMP requirements.
- Provide support for Active Pharmaceutical Ingredient (API) manufacturing processes, ensuring facility and utility systems meet specific requirements for API production.
- Collaborate with API manufacturing teams to optimize facility layouts and equipment installations to enhance efficiency and compliance.
- Develop and maintain facility documentation, including SOPs, technical drawings, and maintenance records.
Requirements
- Bachelor’s Degree in mechanical, electrical, or industrial engineering or equivalent technical experience considered.
- Minimum of five (5) years’ experience in building operations, engineering, and equipment and systems maintenance, with a minimum of three (3) years as a facility engineer or in a similar role preferred.
- Familiarity with GMP pharmaceutical manufacturing facilities, including cleanroom environments and related systems.
- Demonstrated experience with API manufacturing processes and related facility requirements.
- Knowledge of Piping and Instrumentation Diagrams (P&ID’s) and facility drawings.
- Strong analytical and problem-solving skills with attention to detail.
#M3
