Job Description

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 process equipment engineering, with a focus on ensuring compliance with manufacturing processes.

Responsibilities of the Senior Manufacturing Engineer include:

• System Troubleshooting and Support: Provide technical support for process equipment, diagnosing and resolving issues to maintain efficient and compliant operations.
• Project Management: Lead and manage process equipment-related projects, including technology transfers, capital projects, and modifications to existing systems.
• Validation Protocol Management: Develop, execute, and document validation protocols for process equipment and cleaning validation, including Factory Acceptance Testing (FAT) and commissioning efforts.
• Change Control Management: Oversee and manage change controls related to process equipment, ensuring thorough documentation and impact assessments.
• Regulatory Compliance: Support discussions with regulatory authorities (e.g., FDA) and partners, ensuring all process equipment meets engineering and validation standards.
• Continuous Improvement: Identify opportunities for process and system improvements, implementing changes to enhance efficiency and compliance.

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 rug 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.

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