TSMS Operations Engineer, 3rd shift

Essential Job Functions

• Provide real-time technical support to manufacturing operations staff during production activities across all manufacturing areas
• Assist with scaling up and transferring processes into manufacturing by supporting execution of established procedures and protocols
• Support equipment setup, operation, and troubleshooting under guidance of senior technical staff
• Review and assist with GMP manufacturing documentation including Batch Records, Processing Forms, and standard operating procedures
• Monitor Process Data during manufacturing operations and escalate deviations or concerns to senior technical staff
• Aid in technical troubleshooting of routine process issues and support root cause analysis activities under supervision
• Support Process Performance Qualification and Continuous Process Verification activities by collecting data and assisting with documentation
• Participate in cross-functional teams to support manufacturing operations and process improvements
• Afford support for impact assessments of minor changes to processes, equipment, or procedures under supervision
• Support training and development of manufacturing operations staff on technical procedures and best practices
• Maintain detailed records of technical support activities and communicate findings to senior technical staff
• Ensure all activities comply with cGMP regulations, company SOPs, and safety requirements

Special Job Requirements

• Bachelor's degree in Science or Engineering required
• 1-2 years of drug product manufacturing experience preferred
• Strong technical aptitude and problem-solving skills
• Excellent communication skills for working with manufacturing operations teams
• Ability to work in a fast-paced manufacturing environment
• Basic understanding of pharmaceutical manufacturing processes and cGMP requirements
• Proficiency in Microsoft Office applications and basic data analysis