Senior Manufacturing Engineer

4 weeks ago


Durham, North Carolina, United States Technical Source Full time
Job Title: Senior Manufacturing Engineer

Technical Source is seeking an experienced Senior Manufacturing Engineer to join our team in RTP. The ideal candidate will have a strong background in process equipment engineering, with a focus on ensuring compliance with manufacturing processes.

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

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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