Purpose and ScopePosition provides technical support to Tolmar's various packaging and manufacturing sites in Colorado (Fort Collins, Windsor). Addresses equipment specific installations, retrofits, improvements, and updates for both new and existing equipment impacting the Manufacturing and Equipment Engineering Department. Maintains, monitors, and supports the various equipment aspects (i.e. quality, safety, operation, regulations, validation, and testing), and their use for both developmental and commercial applications within Tolmar.
Essential Duties & Responsibilities- Understand design components and features of basic 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 various equipment systems used in the manufacturing areas.
- Author and review technical User Requirements Specifications (URS), Installation/Operational/Performance Qualifications (IQOQPQ) and Change Controls (CC) required for various equipment systems used in manufacturing areas.
- Author and review technical work instructions, Standard Operating Procedures (SOPs), preventative maintenance documents, and recommended spare parts summaries required for various equipment systems used in the manufacturing areas.
- Coordinate with department colleagues to update various manufacturing batch records in order to address any operational impacts from any given equipment installation/change/update.
- Train various departments' (Maintenance, Process Development, Packaging Engineers and Manufacturing) personnel on equipment.
- Drive continuous improvement for quality, efficiency, and safety on new and existing equipment.
- Support, lead and perform investigations, customer complaints, and implement related Corrective And Preventative Actions (CAPA) as 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 as needed.
- Assist in the research of and selection of new/used equipment, parts for modification of equipment, and system integration options.
- Provide support to other departments for products currently in development phase.
- Special projects and other duties as assigned.
Knowledge, Skills & Abilities- Understanding of the various components involved in equipment design/operation including mechanical, electrical, pneumatic, and automation.
- Understanding of PLC logic, Equipment Integration, and Automation concepts.
- Successful coordination of cross functional project teams.
- Experience in a cross-functional team environment.
- Effective written and oral communication skills.
- Ability to handle multiple projects simultaneously.
- Ability to be self-motivated and work effectively both independently and in a team setting.
- Ability to handle ambiguity and remain effective during periods of uncertainty and change.
- Fundamental understanding in analyzing, troubleshooting and identifying problems, and recommending and implementing solutions in a cost-effective manner.
- Working knowledge of various manufacturing equipment (tube & syringe fillers, sealers, crimpers), bottling lines (fillers, cappers, labelers), tray packaging (Thermoformers, cartoners), and vision inspection (track and trace, label inspection) is preferred.
- Proficient in the use of various drafting/prototyping software (i.e. AutoCad, Solidworks, Google Sketch-up, etc.) is preferred.
- Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
- Must possess a valid driver's license and an acceptable MVR.
Education & Experience- 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 including pharmaceutical, health care or medical device manufacturing preferred.
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 time may be required. (International & Domestic)
Compensation and Benefits- Annual pay range $95,000 - $100,000
- 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.
