Technical Source is seeking an experienced Senior Manufacturing Engineer for a leading pharmaceutical manufacturing client in RTP. The ideal candidate will have a strong background in upstream process equipment engineering, with a focus on ensuring compliance with manufacturing processes.
Responsibilities of the Senior Manufacturing Engineer include:
- Troubleshoot and improve process equipment systems in manufacturing.
- Lead process equipment-related projects, including technology transfers, capital projects, and system modifications.
- Update preventative maintenance job plans, equipment standards, drawings, and specifications.
- Provide technical input and guidance for equipment validation and change controls in Tech Transfer efforts.
- Author and approve workflows for equipment/automation-related changes (change controls, deviations, CAPAs) and attend related meetings.
- Manage the development and execution of process equipment and cleaning validation protocols, including floor support during startup and commissioning.
- Collaborate on Factory Acceptance Testing (FAT) and equipment commissioning.
- Support health authority inspections (e.g., FDA) by presenting engineering and validation practices.
Qualifications of the Senior Manufacturing Engineer include:
- Bachelor’s degree or higher in Engineering
- Minimum of 4 years of experience in process equipment engineering
- Proficiency in GMP regulations and guidelines related to process equipment.
- Strong analytical, problem-solving, and project management skills.
- Excellent organizational and communication skills.
Additional Qualifications:
- Willing to submit to a background check
- Willing to submit to drug screen
Compensation for the Senior Manufacturing Engineer includes:
- Salary: $80,000-$120,000 based on experience and qualifications.
- Benefits: Comprehensive package including medical, dental, and vision coverage.
- Note: No Corp to Corp or Visa sponsorships currently.