Apply on Employer Site

INCOG BioPharma Services · 1 month ago

Senior Facilities Engineer (HVAC)

Fishers, Indiana

Full-time

Onsite

Senior Level

5+ years exp

INCOG BioPharma Services is a world-class CDMO focused on parenteral injectable drugs. The Senior Facilities Engineer (HVAC) will provide technical leadership for plant and clean utility systems, particularly in HVAC design and operation within pharmaceutical cleanroom environments.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Qualification

HVAC systems expertiseGMP cleanroom experienceP&ID interpretationCQV activitiesBMS integrationGAMP 5 familiarityRoot-cause analysisContinuous improvementProject presentationTechnical leadership

Required

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)

Serve as the primary technical owner for HVAC systems

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

Preferred

Familiarity with GAMP 5, ISPE Baseline Guides (Sterile, Oral Solid Dosage, Biopharmaceutical), ASHRAE standards, and current regulatory expectations strongly preferred

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees