About the role
The Technical Services and Manufacturing Sciences (TSMS) Operations Engineer will provide direct technical support to manufacturing operations on the production floor in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will work closely with manufacturing operators and supervisors to ensure smooth production operations, troubleshoot technical issues, and support process execution as specified.
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
- Assist with 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
- Assist with 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
- Other responsibilities as required
Special Job Requirements:
- Bachelor's degree in Science or Engineering required
- 1-2 years GMP 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