Process development engineer Jobs in Fort Collins, CO

Core Hours

Sunday - Wednesday, 5:00 pm - 5:30 am (every other Wednesday off)

Training hours may vary

Purpose and Scope

Provides direct supervision of a team of QA associates. Responsible for overseeing the daily operations of the Process Quality team. Provides guidance to ensure compliance with procedures and regulations for QA manufacturing support.

Essential Duties & Responsibilities

• Manage the development, implementation and maintenance of Quality Assurance systems and activities.
• Review and approve documents used in Good Manufacturing Practices through the document management system.
• Provide quality oversight related to manufacturing processes.
• Perform investigations associated with the Quality Operations department.
• Review and approve minor deviations.
• Develop materials for and administer Competency Based Training (CBT).
• Review and approve certificates of analysis for raw materials.
• Identify training needs for direct reports and ensure compliance with training requirements.
• Prepare and administer employee appraisal and performance documentation.
• Assist Manufacturing and QA departments as needed in process improvement projects.
• Provide KPI data for “Right the First Time” for quality operations department.
• Supervise the following activities of QA employees to ensure schedules and performance requirements are met:
• Time off request management
• Material and labeling sampling and inspection
• Finished product sampling and inspection
• Retains of products
• Manufacturing support
• Cleaning and monitoring of inspection areas
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Knowledge in cGMP and ISO 13485.
• Excellent working knowledge of current Good Manufacturing Practices for Finished Pharmaceuticals and/or Medical Devices.
• Skill in effective oral and written communication.
• Skill in Procedure writing.
• Skill in effective computer operation.
• Ability to coordinate activities to assure customer needs are met.
• Ability to work effectively within multi-disciplinary project teams.
• Ability to gain understanding and acceptance from others in sensitive situations.
• Ability to be independent, organized, and to lead others to meet deadlines.

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

• High school diploma or GED required
• Bachelor’s degree in scientific discipline or related field preferred, not required.
• Six or more years of experience in the pharmaceutical or medical device industry in Quality Assurance (or equivalent combination of education and experience).

Working Conditions

• Working conditions are normal for an office environment. Weekends and overtime may be required.

Compensation and Benefits

• Pay: $83,000 - $95,000
• Shift differential: 10%