Senior Equipment Engineer

Tolmar Careers•Windsor, CO

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, with the goals of cost effectiveness, product quality, and on-time performance. The position supports Research & Development teams in identifying and developing process-related equipment and automated control systems for registration batches, scale-up, and commercial shipments. This is not a direct-supervisor role, though the engineer may guide decision-making and coordinate team members toward engineering and technical operations goals. The engineer independently manages complex equipment installations, qualifications, and improvement projects; directs suppliers and contractors; and serves as a subject matter expert in serialization and vision systems. Work takes place in office, laboratory, and manufacturing environments. Occasional weekend and evening work may be required. The annual pay range is $145,000–$160,000, and the position is bonus eligible. Tolmar notes that final compensation may vary based on qualifications and experience and provides a benefits package; further benefits details are available at the company link in the posting.

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, including processing, cleaning, packaging, automation and controls, and installation, qualification, ongoing commercial support, and improvements.
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, cGMP procedures, and 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 to develop effective, creative solutions.

Nice To Haves

Experience with sterile and non-sterile pharmaceutical equipment is preferred.

Responsibilities

Select, purchase, qualify, and provide technical troubleshooting support for equipment used to process, control, package, and transport 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 GMP documentation.
Perform or assist with IQ/OQ and PQ equipment and system validations.
Collaborate with Quality, Maintenance, IT, Project Management, and other departments 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.
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 engineering practices and standards throughout the project lifecycle.
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 with existing manufacturing equipment.
Provide serialization training to maintenance and manufacturing operations technicians.
Perform other related duties as assigned.