Our client is seeking an Equipment Engineer III to provide technical support to various manufacturing sites in Colorado.  This role will address equipment-specific installations, retrofits, improvements, and updates for both new and existing equipment impacting the Equipment Engineering Department. Maintains, monitors, and supports the various equipment aspects (i.e. safety, quality, operation, regulations, validation) and testing, impacting/influencing the evolution of these equipment systems and their use for both developmental and commercial applications.

Responsibilities

• Provide support to production maintenance and manufacturing operations with day to day activities related to bulking, filling, packaging, and serialization equipment as needed.
• Source, purchase, qualify, and support equipment for bulking, filling, and packaging of finished products.
• Support/lead equipment Site Acceptance Testing (SAT) and Factory Acceptance Testing (FAT) as needed.
• Author/edit technical User Requirements Specifications (URS), Installation/Operational Qualifications (IOQ), and Change Controls (CC) required for bulking, filling, and packaging equipment and systems.
• Serve as the subject matter expert for identified equipment.
• Analyze and troubleshoot equipment mechanical/electrical issues or failures to identify root causes and corrective actions.
• Drive continuous improvement on existing equipment aimed at improving safety, quality, uptime, and efficiency.
• Responsible for training maintenance and manufacturing operations technicians and other departments on the use, set-ups, repairs, and maintenance of equipment.
• Support/lead investigations and corrective and Preventative Actions (CAPA) related to equipment issues.
• Provide support to other Departments for products currently in the development phase.
• Promote safety awareness and prevention of accidents and employee involvement with regard to a safe work environment.
• Special projects and other duties as assigned.
• Knowledge of the various (i.e., mechanical, electrical, pneumatic, and automation) components involved in equipment operation.
• Working knowledge of PLC logic, Equipment Integration, and Automation concepts.
• Ability to work well with others in a team environment to provide solutions to complex technical and engineering problems.
• Knowledge of FDA guidelines, cGMP, and other applicable compliance guidelines pertaining to pharmaceutical manufacturing.
• Excellent interpersonal, verbal, and written communication.
• Ability to work in a fast-paced environment with multiple priorities and deadlines.
• Working knowledge of 2D/3D drawing software (i.e., AutoCAD, SolidWorks, etc.).
• Proficient in technical writing and documentation review skills.
• Strong technical abilities to analyze problems, using sound Engineering practices and tools, resulting in effective and creative solutions.
• Knowledge of pharmaceutical manufacturing processes and technologies.

Qualifications

• Bachelor’s degree in Engineering discipline or relevant scientific discipline required.
• Five or more years of engineering experience working with equipment in a manufacturing environment, preferably in a pharmaceutical or related industry.
• Experience with serialization equipment and/or serialization solutions is a plus.

Location

• Windsor, CO

Employment Type

• Direct Hire

Working Conditions

• Working conditions are in an office, laboratory, and manufacturing environment.
• The position may require occasional weekend and/or evening work.
• Must be capable of lifting up to 35 lbs.
• Travel up to 10% of the time may be required (international & domestic).

Compensation and Benefits

• Pay: $110,000 - $120,000 annually, depending on experience
• Bonus eligible
• Benefits

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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