The posting
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
This position is responsible for working closely with team members to maintain all aspects of the facility and its operating equipment
Your role at Clinigen:
Equipment Maintenance & Reliability
- Perform and coordinate preventive, predictive, and corrective maintenance on facility and operational equipment including HVAC, refrigeration, compressed air, temperature monitoring systems, utilities, and production equipment.
- Troubleshoot equipment and facility issues, implement corrective actions, and support equipment installation, qualification, validation, and commissioning activities.
- Ensure equipment remains in a qualified, calibrated, and operational state through effective maintenance and calibration management.
Vendor & Contractor Management
- Serve as the primary site contact for facility and maintenance vendors, including HVAC, pest control, cleanroom certification, calibration, utilities, fire protection, security, and equipment repair providers.
- Schedule, oversee, and evaluate contractor activities to ensure work is completed safely, compliantly, and in accordance with site requirements.
- Maintain vendor-related documentation, service records, work orders, and contractor qualification activities.
Facilities & Safety Compliance
- Promote a strong safety culture and ensure all maintenance and contractor activities comply with EHS, GMP, and company requirements.
- Support facility compliance activities including alarm testing, emergency response drills, inspections, and contractor safety programs.
- Participate in the on-call rotation and respond to facility alarms, equipment failures, and emergency situations as required.
Documentation & Continuous Improvement
- Maintain maintenance records, logs, and facility documentation in compliance with cGMP and GDP requirements.
- Support investigations, deviations, CAPAs, change controls, SOP development, and continuous improvement initiatives related to facilities and equipment reliability.
Requirements
To be successful in this role you should have:
- High school diploma and/or GED with 2-4 years of facilities-related work experience preffered
- Electrical or electromechanical education preferred
- Experience in a cGMP environment preferred
- Knowledge of validation and calibration methodology is preferred
- Experience or certification in controls helpful
- Knowledge and functional understanding of temperature monitoring, security, and fire prevention systems, etc.
- OSHA regulation knowledge is desired
- Knowledge and understanding of how to use calibration equipment, hand tools, power tools, etc.
- Must possess a detailed, proactive approach to management in problem solving of daily operations
- Must be mechanically inclined to handle the following types of equipment: pallet jack, vacuum seal chamber, scales, carding/blistering machines, cryogenic nitrogen chambers, large-scale refrigerators/freezers, time/temperature-dependent equipment
We’re excited about you if you have:
- Experience with MSDS documentation preferred
- Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials is preferred
- Detail orientated to produce accurate work while making timely and sound decisions
- Ability to develop and maintain effective working relationships with co-workers at all levels of the organization
- Must possess a detailed, proactive approach to management in problem solving of daily operations
- Exceptional oral and written communication skills and active listening ability
- Excellent time management skills for working within a fast paced, ever-changing environment
- Self-motivated learner to critically evaluate situations and adapt quickly in making timely and independent decisions
- Confidentiality of all clients’ proprietary and pharmaceutical related information is essential
- Highly computer literate; experience operating with all Microsoft Office software
- Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines)
- Other company proprietary software
Benefits
While at Clinigen, you’ll enjoy:
The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.
The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.
EEO. Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.
