Equipment Engineer II

About the Role

This position provides technical support to Tolmar’s packaging and manufacturing sites in Colorado (Fort Collins, Windsor), addressing equipment installations, retrofits, improvements, and updates. The role maintains, monitors, and supports equipment aspects such as quality, safety, operation, regulations, validation, and testing for both developmental and commercial applications within Tolmar.

Responsibilities

• Understand design components and features of primary (tubes, pumps, jars, syringes, vials, etc.), secondary (cartons, semi-rigid trays, etc.), and tertiary (shippers, etc.) packaging component systems.
• Interact with Original Equipment Manufacturers (OEMs) and 3rd party solution vendors to evaluate options for equipment systems used in manufacturing areas.
• Author and review technical User Requirements Specifications (URS), Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Change Controls (CC) for equipment systems.
• Author and review technical work instructions, Standard Operating Procedures (SOPs), preventative maintenance documents, and recommended spare parts summaries.
• Coordinate with colleagues to update manufacturing batch records to address operational impacts from equipment changes.
• Train personnel from various departments (Maintenance, Process Development, Packaging Engineers, and Manufacturing) on equipment.
• Drive continuous improvement for quality, efficiency, and safety on new and existing equipment.
• Support, lead, and perform investigations, customer complaints, and implement Corrective and Preventative Actions (CAPA) related to equipment issues.
• Support testing activities for equipment line assessments.
• Support and/or lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) and validation execution on new equipment.
• Assist in researching and selecting new/used equipment, parts for modification, and system integration options.
• Provide support to other departments for products in the development phase.
• Handle special projects and other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or similar discipline.
• Three or more years of experience working with equipment in a manufacturing environment.
• Understanding of requirements within a regulated industry (pharmaceutical, health care, or medical device manufacturing) preferred.

Skills

• Understanding of mechanical, electrical, pneumatic, and automation components in equipment design/operation.
• Knowledge of PLC logic, Equipment Integration, and Automation concepts.
• Experience coordinating cross-functional project teams.
• Effective written and oral communication skills.
• Ability to handle multiple projects simultaneously.
• Self-motivated with the ability to work independently and in a team setting.
• Ability to handle ambiguity and remain effective during periods of uncertainty and change.
• Fundamental understanding of problem analysis, troubleshooting, and cost-effective solution implementation.
• Working knowledge of manufacturing equipment (tube & syringe fillers, sealers, crimpers, bottling lines, tray packaging, vision inspection) preferred.
• Proficiency in drafting/prototyping software (AutoCad, Solidworks, Google Sketch-up, etc.) preferred.
• Valid driver’s license and acceptable Motor Vehicle Record (MVR).

Working Conditions

• Office, laboratory, and manufacturing environment.
• Occasional weekend and/or evening work may be required.
• Ability to lift up to 35 lbs.
• Up to 10% travel (international & domestic) may be required.

Pay

Annual pay range: $95,000 - $100,000. Bonus eligible.

Benefits

For benefits information, visit: https://www.tolmar.com/careers/employee-benefits.