Senior Equipment Engineer

Tolmar•Windsor, CO

3h•$145,000 - $160,000

About The Position

The Senior Equipment Engineer designs and implements production equipment and associated automation, controls, and processes for manufacturing and packaging novel delivery system formulations, controlled-release products, and other aseptic products. The role leads cross-functional efforts to establish and maintain strategies, processes, metrics, and engineering standards that improve equipment, systems, and processes to support cost effectiveness, product quality, and on-time performance. It also supports Research & Development in identifying and developing process equipment and automated control systems for production from registration batches and scale-up through commercial shipments. This is not a direct-supervisor position, though the engineer may guide decision-making and coordinate colleagues toward engineering and technical operations goals. The engineer selects, purchases, qualifies, troubleshoots, and improves manufacturing equipment and systems; develops solutions integrating commercial controllers such as PLCs and PACs; prepares GMP documentation; and performs or assists with equipment and system validations. The role independently leads complex installations, qualifications, and improvement projects, manages project plans, suppliers, contractors, and capital budgets, and applies quality-by-design principles throughout the project lifecycle. It serves as a subject matter expert for serialization systems and vision systems, including integration with existing manufacturing equipment, and provides serialization training to maintenance and manufacturing technicians. Work takes place in office, laboratory, and manufacturing environments. Occasional weekend and evening work may be required. The position is bonus eligible, with an annual pay range of $145,000–$160,000. Tolmar describes its compensation programs as including market-based base pay and a strong benefits package; further benefits information is provided through the company’s employee-benefits webpage.

Requirements

Bachelor’s degree in Engineering.
Eight or more years of experience in an engineering-related role in the pharmaceutical or medical device industry.
Four or more years of experience working with serialization systems.
Engineering experience with pharmaceutical equipment installation, qualification, ongoing commercial support, and improvements across processing, cleaning, packaging, automation and controls, and sterile and non-sterile equipment.
Technical expertise in one or more process engineering areas.
Understanding of PLC logic, equipment integration, and automation concepts.
Expert knowledge of serialization systems from Levels 1 through 4.
Understanding of vision systems, including Optel, SeaVision, Cognex, and Keyence.
Expert knowledge of FDA guidelines and cGMP procedures, and knowledge of current trends.
Excellent professional written and verbal communication and interpersonal skills.
Ability to independently manage multiple projects with minimal supervision.
High attention to detail and a strong sense of personal responsibility.
Senior-level technical ability to analyze complex problems using sound engineering practices and tools and develop effective, creative solutions.

Responsibilities

Select, purchase, qualify, and provide technical troubleshooting support for equipment used to process, control, package, and transport raw ingredients, formulations, intermediates, work in process, and finished products.
Develop engineering solutions integrating commercial controllers, including PLCs and PACs.
Write protocols, reports, batch records, procedures, and other required controlled GMP documentation.
Perform or assist with IQ/OQ and PQ validations of equipment and systems.
Collaborate with departments such as Quality, Maintenance, IT, and Project Management to troubleshoot and optimize equipment and processes through root cause analysis, engineering studies, DOE studies, and appropriate metrics.
Mentor team members and cross-functional project teams and provide senior-level technical guidance.
Independently manage complex equipment installations, qualifications, and improvement projects.
Create and manage complex project plans to achieve project milestones.
Manage and direct third-party suppliers and contractors, including associated capital budgets and expenses.
Develop process and product knowledge and apply quality-by-design principles and effective engineering practices and standards throughout project lifecycles.
Serve as the subject matter expert for serialization hardware and software, including integration with existing manufacturing equipment.
Serve as the subject matter expert for vision systems, including integration into existing manufacturing equipment.
Provide serialization training to maintenance and manufacturing operations technicians.
Perform other related duties as assigned.