Project Engineer 2

Creative Solutions Services, LLC; Vacaville (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an HVAC engineer to support pharmaceutical facilities in Vacaville, California. You will design, review, and optimize HVAC systems to ensure GMP compliance, cleanroom integrity, and reliable operation.

Collaborate with operations, maintenance, and project teams on commissioning, qualification, and energy efficiency improvements, while maintaining regulatory documentation.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Typically 3–8+ years in HVAC engineering or utilities systems.
• Experience in pharmaceutical, biotech, or regulated environments preferred.

Responsibilities

• Design, review, and modify HVAC systems (AHUs, ducts, airflow).
• Provide troubleshooting support for HVAC failures or deviations.
• Support commissioning, qualification, and requalification.
• Lead or support capital projects and energy efficiency improvements.
• Ensure HVAC systems meet FDA, GMP regulatory requirements.

Skills

HVAC design

GMP/regulatory awareness

Cleanroom environments

Troubleshooting & diagnostics

Project coordination

Education

Bachelor's degree in Mechanical Engineering

Job description

Job Description

Provide engineering support for Heating, Ventilation, and Air Conditioning (HVAC) systems to ensure reliable, compliant, and efficient operation of facility and manufacturing environments. This role supports operations, maintenance, and capital projects within Utilities and Facilities Engineering. HVAC systems are critical for controlling temperature, humidity, airflow, cleanliness, and pressure, which directly impacts product quality and regulatory compliance in pharmaceutical environments.

Responsibilities

Technical & Engineering

• Design, review, and modify HVAC systems, including:
• Air Handling Units (AHUs), ducting, and airflow systems.
• Heating, cooling, humidification, and filtration systems.
• Perform engineering calculations (airflow, load, pressure, energy).
• Ensure compliance with GMP, GEP, and site standards for controlled environments.
• Review and approve HVAC-related drawings, specifications, and change records.
• Support system commissioning, qualification, and requalification.

Operations Support

• Provide troubleshooting support for HVAC system failures or deviations.
• Analyze system performance issues (e.g., airflow imbalance, temperature instability).
• Work closely with maintenance and operations teams to resolve issues in real time.
• Participate in on-call or off-hours support when required (common in utilities roles).

Automation & Controls (Client Integration)

• Support HVAC systems integrated with Building Automation Systems (Client), including.
• Monitoring alarms and trends.
• Troubleshooting system malfunctions.
• Reviewing and implementing automation changes.
• HVAC systems are commonly monitored via Client platforms (e.g., Siemens Desigo), which also handle site utility alarms and regulatory monitoring.

Projects & Continuous Improvement

• Lead or support capital projects and upgrades (retrofits, expansions, efficiency improvements).
• Identify energy and sustainability opportunities (e.g., airflow optimization, heat recovery).
• Support retro commissioning efforts to improve system performance and reliability.
• Assist in developing and executing project scopes, timelines, and budgets.

Compliance & Documentation

• Ensure HVAC systems meet regulatory and quality requirements (FDA, GMP).
• Support audits, inspections, and deviation investigations.
• Develop and maintain.
• SOPs and engineering standards.
• Change controls and validation documentation.
• Provide technical input for permits and safety reviews

Requirements

• Bachelor's degree in Mechanical Engineering or related field.
• Typically 3-8+ years in HVAC engineering or utilities systems.
• Experience in pharmaceutical, biotech, or regulated environments preferred.

Skills & Competencies

• Strong understanding of:
• HVAC system design and operation.
• Cleanroom and controlled environments.
• Client/controls systems.
• Problem-solving and troubleshooting capability.
• Ability to manage multiple projects and priorities.
• Strong collaboration with operations, quality, and maintenance teams.