Equipment Engineering Lead — Automation & Serialization

Tolmar Inc.; Windsor (CO); On-site; USD 110,000 - 170,000; Full time

Job summary

Tolmar Inc. in Windsor, Colorado, seeks a Senior Equipment Engineer to design and implement production equipment, automation, controls, and processes for pharmaceutical manufacturing and aseptic products.

Lead cross-functional efforts to establish standards, metrics, and cost-effective improvements across projects. Collaborate with R&D to identify equipment and automated control systems for scale‑up to registration batches and final shipments.

Qualifications

• Bachelor’s degree in engineering required.
• Eight or more years in engineering in the pharmaceutical or medical device industry.
• Four or more years working with serialization systems.
• Engineering experience with equipment installation, qualification, and ongoing commercial support and improvements.

Responsibilities

• Select, purchase, qualify and support equipment for processing, packaging, and transport of raw ingredients and finished products.
• Write protocols, reports, batch records, procedures and GMP documentation; assist IQ/OQ and PQ validations.
• Perform root cause analysis and DOE studies to optimize equipment and processes.
• Mentor team members and coordinate cross-functional projects; manage complex installations/qualifications.
• Create and manage project plans; oversee third party suppliers; manage capital budgets.
• Apply quality by design principles across the project lifecycle.
• Serve as SME for serialization hardware and software integration with manufacturing equipment.
• Serve as SME for vision systems integration with manufacturing equipment.
• Provide serialization training to maintenance and manufacturing operations technicians.

Skills

Process engineering

PLC logic & integration

Serialization systems

Vision systems

FDA/cGMP knowledge

Cross-functional leadership

Education

Bachelor's degree in Engineering

Job description

Tolmar Inc. in Windsor, Colorado, seeks a Senior Equipment Engineer to design and implement production equipment, automation, controls, and processes for pharmaceutical manufacturing and aseptic products.

Lead cross-functional efforts to establish standards, metrics, and cost-effective improvements across projects. Collaborate with R&D to identify equipment and automated control systems for scale‑up to registration batches and final shipments.