Upstream Process Engineer - Technical Source

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.