Harrowhealth1mo ago

Facilities & Maintenance Manager

Ledgewood Njmid

Other

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going.

Technical Tools

Other

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

An expanding Retina Portfolio including IHEEZO^®, TRIESENCE^®, BYOOVIZ^TM, and OPUVIZ^TM
A broad Dry Eye Disease product line, led by VEVYE^® and bolstered by well-known adjacent ocular surface disease products such as FLAREX^® and FRESHKOTE^®
A peri-operative Surgical product line, led by TRIESENCE^®, and BYQLOVI^TM
A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO^®, NATACYN^®, and VERKAZIA^®
A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

The Facilities & Maintenance Manager is a hands-on technical leader responsible for the daily reliability, performance, and compliance of facility, utility, manufacturing, filling, and packaging systems across the 503A and 503B operations. This role is actively engaged on the production floor, directly troubleshooting equipment, leading maintenance execution, and driving real-time solutions that protect sterile operations and business continuity.

Responsibilities

~2 min read

→Develop and lead maintenance team through direct floor engagement, accountability, training, and performance management.
→Full ownership of site-wide maintenance across manufacturing, filling, packaging, utilities, and infrastructure for 503A and 503B operations.
→Ensure >98–100% on-time preventive and predictive maintenance execution; drive rapid response to equipment failures.
→Lead hands-on troubleshooting of critical systems including HVAC, cleanrooms, water for Injection, compressed gases, and sterile processing equipment.
→Own and manage the complete calibration program; maintain 100% compliance and audit readiness.
→Investigate out-of-tolerance and equipment-related deviations; implement effective root cause and CAPA solutions.
→Serve as system owner for BMRAM (CMMS); ensure accurate asset records, timely work order closure, KPI tracking, and data integrity.
→Own Lighthouse environmental monitoring system; ensure continuous ISO compliance, alarm functionality, trend review, and excursion management.
→Maintain validated state of facilities, utilities, and monitoring systems; support inspections as technical SME.
→Lead capital projects from specification through commissioning (URS, FAT, SAT, IOQ, PQ) with direct contractor oversight.
→Control maintenance and calibration budgets while optimizing spare parts inventory and reliability metrics (MTBF, downtime reduction).
→Drive continuous improvement initiatives using Lean/Kaizen to enhance uptime, throughput, and GMP compliance.
→Develop and implement solutions to difficult problems, manage outside contractors and be on call for emergencies.
→Manage spare parts inventory to balance cost control with operational reliability.
→Ensure facility and utility systems consistently meet ISO classifications, pressure cascades, and environmental control requirements.
→Lead change management, risk assessments (FMEA), and impact evaluations related to facility, equipment, and utility modifications.
→Coordinate and oversee third-party contractors and service providers to ensure GMP-compliant execution and documentation.
→Partner cross-functionally with Operations, Quality, Validation, and Supply Chain to align maintenance strategy with production readiness and business continuity objectives.

Requirements

~1 min read

Bachelor’s degree in Mechanical or Electrical Engineering preferred; equivalent hands-on experience considered.
Minimum 5 years in GMP pharmaceutical manufacturing.
Minimum 3 years managing maintenance teams in sterile or regulated environments.
Demonstrated hands-on troubleshooting of manufacturing equipment and critical utilities.
Direct experience managing CMMS systems (BMRAM or equivalent).
Experience overseeing environmental monitoring systems (Lighthouse or equivalent).
Strong knowledge of HVAC, cleanroom classifications, utilities, and GMP documentation practices.
Experience supporting regulatory inspections.Commitment and drive to improve manufacturing operations.
Perform other duties, as assigned.