MS&T Manufacturing Operations Engineer

Responsibilities

• Provide technical support for manufacturing processes for specialty injectable and aseptic products
• Serve as the system owner for Electronic Batch Records (EBR) and Freeweigh systems
• Own manufacturing change controls associated with CAPA actions and process improvements
• Manage Quality Event investigations and support equipment troubleshooting, updating, and installation
• Use data analysis tools to identify and resolve manufacturing process issues impacting quality and efficiency
• Write, edit, and route Work Instructions and SOPs within the electronic document management system
• Support new equipment qualifications, installations, and calibrations
• Act as a technical liaison between Manufacturing and other departments for cross-functional projects

Requirements

• Bachelor's degree in engineering or a similar scientific field
• Strong understanding of current Good Manufacturing Procedures (cGMP)
• Knowledge of US and European Industry Regulations pertaining to cleanroom production
• Experience with Electronic Document Management Systems (EDMS)
• Proficiency in Microsoft Office (Excel, Word, Outlook) and Adobe
• Strong technical writing and mathematical skills
• Ability to work onsite in Windsor, CO

Preferred Qualifications

• One or more years of experience in a GMP manufacturing role within the pharmaceutical or medical device industry
• Experience with advanced or complex manufacturing processes

About the Company

Tolmar is a pharmaceutical company dedicated to supporting the well-being of patients through high-quality specialty products. We operate with a culture of engagement, agility, and ethical conduct, constantly striving to improve our processes and systems to deliver extraordinary outcomes.