Senior Facilities Engineer (HVAC)
Description
Position Overview
The Senior Facilities Engineer (HVAC) will support the plant and clean utilities at INCOG BioPharma’s Fishers, Indiana location. The candidate will be the subject matter expert and system owner of all facility utilities, with a strong emphasis on HVAC systems that support GMP cleanroom manufacturing environments (Grade A–D) as well as the full suite of plant and clean utilities.
Essential Job Functions
· Provide engineering technical leadership and expertise for all plant and clean utility systems, with particular depth in HVAC design, operation, troubleshooting, and optimization in pharmaceutical cleanrooms.
· Serve as the primary technical owner for HVAC systems.
· Understand and interpret Piping and Instrumentation Diagrams (P&IDs), HVAC control schematics, psychrometric charts, and airflow diagrams; understand design intent and make recommendations for best practices in design, operation, and energy efficiency.
· Lead or support commissioning, qualification, and validation (CQV) activities for new or modified HVAC and utility systems.
· Author change controls, SOPs, and maintenance procedures; contribute to deviation investigations and CAPA development.
· Drive continuous improvement activities for operational efficiency.
· Provide technical solutions to complex utility problems, including root-cause analysis of temperature/humidity excursions, microbial control issues, and airflow imbalances.
· Participate in interdisciplinary project teams for capacity expansions, new suite builds, and technology transfers that involve utility modifications.
· Present complex technical topics, root-cause analyses, and project updates to site leadership.
Special Job Requirements
· Bachelor’s degree in Engineering (Mechanical, Chemical, or Biomedical preferred).
· Minimum of 5 years of hands-on experience with plant utilities and HVAC systems in a pharmaceutical, biotech, or other FDA-regulated manufacturing environment.
· Demonstrated expertise in pharmaceutical-grade HVAC systems (cleanroom classification, single-pass vs. recirculating designs, precise environmental control, BMS integration).
· Familiarity with GAMP 5, ISPE Baseline Guides (Sterile, Oral Solid Dosage, Biopharmaceutical), ASHRAE standards, and current regulatory expectations strongly preferred.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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