Equipment Engineer III Job at Tolmar Inc. in Windsor

Purpose and Scope

The Equipment Engineer III provides technical support to Tolmar’s various manufacturing sites in Colorado (Fort Collins, Windsor). Addresses 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 within Tolmar.

Essential Duties & Responsibilities

• Lead the sourcing, procurement, installation and qualification of equipment for serialization, 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) 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, 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 regards to safe work environment.
• Special projects and other duties as assigned.

Knowledge, Skills & Abilities

• 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.

Core Values

• The Equipment Engineer III is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency no matter the task.

Education & Experience

• 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 pharmaceutical or related industry.
• Experience with serialization equipment and/or serialization solutions is a plus.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment.
• 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 information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.