Senior Equipment Engineer

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

Design and implement production equipment and associated automation, controls, and processes to be used in the manufacturing and packaging of novel delivery system formulations and controlled release products as well as other aseptic products. The Senior Equipment Engineer is responsible for leading cross functional efforts to establish and maintain strategies, processes, metrics, and engineering standards for improving equipment, systems, and processes to achieve cost effectiveness, improve product quality and on-time performance. The position will also support the Research & Development teams, in identification and development of process related equipment and automated control systems to be used in the production of registration batches through scale-up and final commercial shipments to Tolmar’s customers. A person in the senior role is not a direct supervisor, but may take on a leadership role to guide decision making and coordinate efforts of other team members toward engineering and technical operation’s goals.

• Select, purchase, qualify and support technical trouble shooting of equipment for processing, controlling, packaging, and transporting raw ingredients, formulations, intermediates, work in process, and/or finished products. Develop engineering solutions using the integration of several types of commercial controllers which include PLCs, PACs, etc..
• Write protocols, reports, batch records, procedures and other controlled and necessary GMP documentation. Perform or assisting IQ/OQ and PQ validations of equipment and systems.
• Actively pursues collaborative cooperation with other departments (Quality, Maintenance, IT, Project Management, etc.) in troubleshooting and optimizing equipment and related processes, by performing root cause analysis, engineering studies, DOE studies, implementing appropriate metrics to improve existing equipment and processes.
• Provide senior level mentoring to team members and cross functional project teams to promote excellence. Independently manage complex equipment installations/qualifications, or improvement projects.
• Creates and manages complex project plans for successful execution of project milestones. Effectively manages and directs third party suppliers and contractors, along with associated capital budgets and expenses.
• Take ownership of developing process/product knowledge by applying quality by design principles and effective engineering practices and standards throughout the project lifecycle.
• Serve as the subject matter expert for serialization hardware and software, including integration to 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.

Knowledge, Skills & Abilities

• Technical expert 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 visions 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 sense of personal responsibility.
• Senior level technical abilities to analyze complex problems, using sound Engineering practices and tools, resulting in effective and creative solutions.

Core Values

This position is expected to operate within the framework of Tolmar’s Core Values:

• Center on People: We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity,inclusion& sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor’s Degree in Engineering required.
• Eight or more years’ experience in engineering related role in the pharmaceutical or medical device industry.
• Four or more years working with serialization systems.
• Engineering experience with all aspects of pharmaceutical equipment (processing, cleaning, packaging, automation and controls, sterile and non‑sterile preferred) installation, qualification, and on‑going commercial support and improvements.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment. Work may require occasional weekend and/or evening work.

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.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.