Purpose & Scope
The Equipment Engineer III provides technical support for manufacturing sites in Colorado, focusing on equipment installations, retrofits, improvements, and updates. This role involves maintaining safety, quality, and operational standards for equipment used in developmental and commercial applications.
Essential Duties & Responsibilities
- Support production maintenance and operations for bulking, filling, packaging, and serialization equipment.
- Source, purchase, qualify, and support equipment for manufacturing.
- Lead Site Acceptance Testing (SAT) and Factory Acceptance Testing (FAT).
- Create and edit User Requirements Specifications (URS) and Installation/Operational Qualifications (IOQ).
- Act as a subject matter expert for specific equipment.
- Troubleshoot mechanical and electrical equipment issues to identify root causes.
- Drive continuous improvement in safety, quality, uptime, and efficiency.
- Train technicians and other departments on equipment use and maintenance.
- Support investigations and Corrective and Preventative Actions (CAPA) for equipment issues.
- Assist with products in development.
- Promote safety awareness in the workplace.
- Undertake special projects and additional duties as assigned.
Knowledge, Skills & Abilities
- Familiarity with mechanical, electrical, pneumatic, and automation components.
- Understanding of PLC logic and equipment integration.
- Team-oriented problem-solving skills for technical issues.
- Knowledge of FDA guidelines and cGMP compliance.
- Strong communication and documentation skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in 2D/3D drawing software (e.g., AutoCAD, SolidWorks).
- Technical aptitude for analyzing and solving engineering problems.
- Understanding of pharmaceutical manufacturing processes.
Core Values
- Uphold the highest ethical standards and compliance.
- Take ownership of actions and outcomes.
- Collaborate respectfully for company success.
- Go the extra mile to achieve goals.
- Commit to our mission and the patients we serve.
- Embrace change with enthusiasm.
- Act quickly to meet customer and patient needs.
Education & Experience
- Bachelor's degree in Engineering or a relevant scientific discipline.
- Minimum of five years of engineering experience in a manufacturing environment, preferably in pharmaceuticals.
- Experience with serialization equipment is a plus.
Working Conditions
- Office, laboratory, and manufacturing environments.
- Occasional weekend and evening work may be required.
- Ability to lift up to 35 lbs.
- Travel up to 10% may be necessary.
