Pharma Facilities Engineer: GMP & Capital Projects

ER Associates, Inc.; Englewood (CO); Hybrid; USD 120,000 - 160,000; Full time

Job summary

ER Associates in Englewood, CO, is seeking a Facility Engineering Manager to lead facility engineering operations, capital projects, utilities, equipment, and infrastructure within a highly regulated pharmaceutical manufacturing environment.

The successful candidate will report to senior Facilities and Engineering leadership and manage day-to-day activities, coordinate vendors, and ensure facility systems stay safe, compliant, reliable, and ready to support manufacturing operations.

Qualifications

• Minimum 5 years of experience managing facilities or facility engineering in a cGMP/FDA-regulated pharmaceutical manufacturing environment.
• 2+ years of experience in an aseptic processing facility preferred.
• Strong knowledge of cGMP guidelines and pharmaceutical manufacturing standards.

Responsibilities

• Manage daily Facility Engineering activities, including facility systems, utilities, equipment, and infrastructure.
• Support and manage capital projects, facility modifications, upgrades, expansions, and equipment installations.
• Coordinate performance inspections of HVAC, plumbing, electrical, boilers, mechanical systems, and other facility utilities.
• Manage site activities necessary for successful execution of facility and capital projects.
• Coordinate with internal teams and external vendors to ensure projects are executed safely and according to requirements.
• Ensure facility operations comply with OSHA, cGMP, FDA, and other regulatory requirements.
• Collaborate with Maintenance to develop preventive maintenance programs.
• Ensure Engineering, Project, and Maintenance documentation remains up to date.
• Partner with Production and Quality teams to ensure facility readiness for manufacturing operations.
• Support identification and resolution of facility technical issues throughout lifecycle.

Skills

Project management

Facility engineering

Regulatory compliance

Communication

Organizational skills

Problem solving

Education

Bachelor's degree in engineering

Technical or engineering degree preferred

Tools

Microsoft Project

Outlook

Excel

Word

Job description

Facility Engineer
Location: Englewood, CO, 80112
Industry: Pharmaceutical Manufacturing
Work Environment: GMP-Regulated Manufacturing Facility

Position Summary

A leading pharmaceutical manufacturing organization is conducting asearch for a Facility Engineering Manager to support facility engineering operations, capital projects, utilities, equipment, and infrastructure within a highly regulated manufacturing environment.

This position will report to senior Facilities and Engineering leadership and will be responsible for managing day-to-day facility engineering activities, supporting capital projects, coordinating vendors, and ensuring facility systems remain safe, compliant, reliable, and ready to support manufacturing operations.

The ideal candidate will have strong experience in a cGMP and FDA-regulated pharmaceutical manufacturing environment, along with demonstrated project management expertise and a strong understanding of facility systems.

Key Responsibilities

• Manage daily Facility Engineering activities, including facility systems, utilities, equipment, and infrastructure.
• Support and manage capital projects, facility modifications, upgrades, expansions, and equipment installations.
• Conduct and/or coordinate performance inspections of HVAC, plumbing, electrical, boilers, mechanical systems, and other facility utilities.
• Manage site activities necessary for successful execution of facility and capital projects.
• Coordinate with internal teams and external vendors to ensure projects are executed safely, efficiently, and according to established requirements.
• Ensure facility operations comply with applicable OSHA, cGMP, FDA, and other regulatory requirements.
• Collaborate with Maintenance teams to develop and implement effective preventive maintenance programs.
• Ensure Engineering, Project, and Maintenance documentation remains accurate and up to date.
• Partner with Production and Quality teams to ensure facility readiness for manufacturing operations.
• Support the identification and resolution of facility technical issues throughout the equipment and facility lifecycle.
• Ensure equipment and facility systems are properly handed over to end users following repairs, preventive maintenance, modifications, and projects.
• Apply facilities engineering expertise to improve operating procedures, design specifications, technical documentation, and departmental processes.
• Support vendor management and third-party contractors involved in facility projects and modifications.
• Ensure all facility-related work is performed safely and in accordance with applicable industry standards.
• Support continuous improvement initiatives across Facilities and Engineering operations.
• Perform other duties as assigned by senior Facilities and Engineering leadership.

Required Qualifications

• Minimum 5 years of experience managing facilities or facility engineering within a cGMP/FDA-regulated pharmaceutical manufacturing environment.
• 2+ years of experience in an aseptic processing facility preferred.
• Strong knowledge of cGMP guidelines and pharmaceutical manufacturing standards.
• Bachelor's degree required; technical or engineering degree preferred.
• Demonstrated project management experience.
• Experience managing capital projects and facility remodels involving GMP-regulated spaces.
• Strong understanding of facility systems, including HVAC, electrical, plumbing, mechanical systems, boilers, and utilities.
• Strong written and verbal communication skills, including presentation capabilities.
• Strong organizational skills and ability to manage multiple priorities.
• Results-oriented approach with strong problem-solving and decision-making abilities.
• Proficiency with Microsoft Project, Outlook, Excel, and Word.

Facility Engineer
Location: Englewood, CO, 80112
Industry: Pharmaceutical Manufacturing
Work Environment: GMP-Regulated Manufacturing Facility

Position Summary

A leading pharmaceutical manufacturing organization is conducting asearch for a Facility Engineering Manager to support facility engineering operations, capital projects, utilities, equipment, and infrastructure within a highly regulated manufacturing environment.

This position will report to senior Facilities and Engineering leadership and will be responsible for managing day-to-day facility engineering activities, supporting capital projects, coordinating vendors, and ensuring facility systems remain safe, compliant, reliable, and ready to support manufacturing operations.

The ideal candidate will have strong experience in a cGMP and FDA-regulated pharmaceutical manufacturing environment, along with demonstrated project management expertise and a strong understanding of facility systems.

Key Responsibilities

• Manage daily Facility Engineering activities, including facility systems, utilities, equipment, and infrastructure.
• Support and manage capital projects, facility modifications, upgrades, expansions, and equipment installations.
• Conduct and/or coordinate performance inspections of HVAC, plumbing, electrical, boilers, mechanical systems, and other facility utilities.
• Manage site activities necessary for successful execution of facility and capital projects.
• Coordinate with internal teams and external vendors to ensure projects are executed safely, efficiently, and according to established requirements.
• Ensure facility operations comply with applicable OSHA, cGMP, FDA, and other regulatory requirements.
• Collaborate with Maintenance teams to develop and implement effective preventive maintenance programs.
• Ensure Engineering, Project, and Maintenance documentation remains accurate and up to date.
• Partner with Production and Quality teams to ensure facility readiness for manufacturing operations.
• Support the identification and resolution of facility technical issues throughout the equipment and facility lifecycle.
• Ensure equipment and facility systems are properly handed over to end users following repairs, preventive maintenance, modifications, and projects.
• Apply facilities engineering expertise to improve operating procedures, design specifications, technical documentation, and departmental processes.
• Support vendor management and third-party contractors involved in facility projects and modifications.
• Ensure all facility-related work is performed safely and in accordance with applicable industry standards.
• Support continuous improvement initiatives across Facilities and Engineering operations.
• Perform other duties as assigned by senior Facilities and Engineering leadership.

Required Qualifications

• Minimum 5 years of experience managing facilities or facility engineering within a cGMP/FDA-regulated pharmaceutical manufacturing environment.
• 2+ years of experience in an aseptic processing facility preferred.
• Strong knowledge of cGMP guidelines and pharmaceutical manufacturing standards.
• Bachelor's degree required; technical or engineering degree preferred.
• Demonstrated project management experience.
• Experience managing capital projects and facility remodels involving GMP-regulated spaces.
• Strong understanding of facility systems, including HVAC, electrical, plumbing, mechanical systems, boilers, and utilities.
• Strong written and verbal communication skills, including presentation capabilities.
• Strong organizational skills and ability to manage multiple priorities.
• Results-oriented approach with strong problem-solving and decision-making abilities.
• Proficiency with Microsoft Project, Outlook, Excel, and Word.

“ TalentBridge employees are eligible for many benefit offerings such as medical, dental, vision, life insurance, short term disability, 401(k) and holiday pay!”