Sustaining Engineer

2 weeks ago

Camarillo, California, United States SaniSure LLC Full time
Job Description

SaniSure LLC is a leading manufacturer of single-use bioprocessing solutions for the production of biological drugs. As a Sustaining Engineer, you will play a critical role in ensuring the quality and reliability of our products.

Key Responsibilities:

  • Lead continuous improvement initiatives to enhance product performance and manufacturing efficiency.
  • Collaborate with cross-functional teams to resolve product and manufacturing process concerns.
  • Develop and implement design for manufacture and assembly (DFMA) principles to optimize product design and manufacturing processes.
  • Conduct process verification and validation testing to ensure compliance with regulatory requirements.
  • Drive capital equipment requests and qualification to support manufacturing operations.
  • Lead yield improvements, reduce variability, and support manufacturing in resolving technical problems.
  • Perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
  • Support customer complaint investigations and analyze complaint data to identify and address systemic design issues.
  • Support audits, resolve CAPAs and NCRs, and drive continuous improvement initiatives.

Requirements:

  • Bachelor's degree in Engineering; Master's preferred.
  • 8+ years of hands-on design and development experience in plastic design and manufacturing or related industry.
  • Design verification and process verification/validation protocol and report writing experience.
  • Design control, change control, and risk management experience (DFMEA, PFMEA).
  • Strong organizational and time management skills, with ability to work independently and problem solve with minimal supervision.
  • Ability to communicate effectively, both verbally and in writing, with strong interpersonal skills.
  • Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.
  • Ability and willingness to travel up to 10%, including occasional international travel.

About SaniSure LLC:

SaniSure LLC is a multinational manufacturer of single-use bioprocessing solutions. We operate a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Our products are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of biological drugs.

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