HEMA Biologics · 1 day ago
Sr Facilities Engineer
Philadelphia, PA, Philadelphia, PA, US
Full-time
Onsite
Senior Level
$100K/yr - $125K/yr
7+ years expHEMA Biologics is seeking a Sr. Facilities Engineer responsible for maintaining process equipment and utilities to support GMP manufacturing. This role involves overseeing calibrations, troubleshooting, and driving continuous improvement initiatives to enhance operational reliability and compliance.
BiopharmaBiotechnology
Responsibilities
Partner with CMC, Manufacturing, Quality, and Facilities teams to understand core business objectives and ensure calibration and maintenance strategies align with operational, regulatory, and commercial readiness requirements
Own and oversee the utility and process equipment calibration program in compliance with cGMP and GDP requirements, ensuring a high level of equipment reliability, data integrity, and continuous inspection readiness
Evaluate the effectiveness of individual equipment calibration strategies and collaborate with asset owners and Quality to implement risk-based improvements that enhance performance and compliance
Serve as the technical lead for identifying, investigating, and resolving calibration and equipment performance deficiencies using structured root cause analysis and sound engineering judgment
Initiate and actively participate in GMP investigations, deviations, CAPAs, and change control processes related to calibration, maintenance, and equipment performance
Develop, maintain, and execute department self-audit programs for equipment repair and maintenance activities, including:
1. Creating audit checklists
2. Conducting audits
3. Preparing reports
4. Recommending and tracking corrective actions
Manage and forecast calibration-related budgets by tracking expenses, analyzing trends, and supporting annual maintenance cost planning
Supervise and manage third-party service providers, including:
1. Scheduling and coordinating services
2. Escorting vendors in GMP and cleanroom environments
3. Ensuring work is performed in accordance with US WorldMeds EHS, GMP, and quality requirements
4. Verifying documentation is complete, accurate, and recorded at the time of service
Align calibration and maintenance activities with manufacturing schedules to ensure work is completed before due dates while minimizing production impact
Independently review and analyze equipment history, trends, and performance data to identify reliability risks and recommend improvements to calibration and maintenance strategies
Identify, procure, and maintain inventories of critical spare parts, calibration standards, and standby equipment necessary to support maximum operational capacity and system reliability
Respond to equipment, building, and utility alarms after hours on a rotational basis, including acknowledging alarms through the BMS and supporting emergency troubleshooting and resolution
Participate in the evaluation of Facilities-related process gaps and contribute to cross-functional efforts to close compliance, efficiency, and reliability gaps
Research industry best practices, engage in professional networking, and apply technical expertise to develop and recommend commercial-level calibration and maintenance process improvements
Assess the effectiveness of implemented improvements and report findings, trends, and recommendations to asset owners and leadership
Ensure all calibration records are organized, complete, accurate, and maintained in strict accordance with GDP requirements
Perform all activities in compliance with applicable cGMP regulations and relevant FDA, USP, and ISPE guidelines
Champion GMP compliance, data integrity, and maintenance best practices to support a best-in-class calibration and reliability program
Develop, revise, and maintain SOPs, work instructions, and technical documentation related to calibration and maintenance processes
Serve as the internal audit lead for Facilities processes related to equipment maintenance and calibration, including gap analysis, documentation of findings, and recommendations for corrective actions
Provide technical mentorship and guidance to junior engineers, technicians, and cross-functional partners as needed
Perform additional duties and special projects as assigned in support of a rapidly growing and evolving organization
Qualification
Required
Bachelor's degree in Engineering required with 7–10+ years of experience in pharmaceutical or biotech manufacturing, including process equipment support, calibration, and GMP compliance
Demonstrated commitment to precision, accuracy, and high-quality workmanship in all technical and compliance-related activities
Strong written and verbal communication skills with a proven ability to work effectively in highly collaborative, team-based environments
Excellent analytical, troubleshooting, and critical-thinking skills, with hands-on experience diagnosing and resolving equipment and utility performance issues
Proven ability to partner effectively with both technical and non-technical stakeholders across all levels of the organization
High-energy, results-oriented professional with a confident yet approachable demeanor and a strong bias for action
Availability to participate in a scheduled rotational on-call program to respond to after-hours equipment and utility emergencies
Experience using computerized maintenance management systems (CMMS), such as Blue Mountain or equivalent platforms
This role is fully on-site, requiring five days per week in-office presence
Hands-on calibration experience across a broad range of process equipment and utility systems in a GMP-regulated manufacturing environment
Working knowledge of GMP Quality Management Systems, including deviations, investigations, CAPAs, and change controls
Strong ability to analyze raw calibration and performance data, interpret results, and determine appropriate corrective actions
Proven ability to consistently apply standardized work methods with a high level of precision to ensure data integrity and quality outcomes
Experience completing and maintaining GMP-compliant documentation related to calibration, maintenance, and equipment activities
Demonstrated ability to organize and manage calibration schedules using Excel, CMMS, or other electronic tools to ensure all work is completed within required due dates
Exceptional organizational skills and adaptability, with the resilience to manage conflicting priorities and rapidly changing schedules
Ability to work independently with minimal supervision while also thriving in a collaborative team environment
Experience working in and gowning for GMP cleanroom environments
Highly collaborative mindset with strong alignment to business objectives, organizational values, and strategic priorities
Prior experience supporting complex biotechnology and/or pharmaceutical manufacturing operations
Preferred
Advanced degree preferred
Formal training and/or certification in metrology are strongly preferred
Experience within the biopharmaceutical or pharmaceutical manufacturing industry
Working knowledge of AutoCAD or similar engineering drawing software preferred
Company
HEMA Biologics
HEMA Biologics is a privately-held biopharmaceutical company focused on patients living with the rarest bleeding disorders.
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-03-12
Company data provided by crunchbase