Senior Validation Engineer

4 weeks ago


Daly City, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Write technical documents associated with projects.
  • Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems.
  • Perform (hands on) field execution of commissioning and/or validation documentation.
  • Reviewing equipment lists, instrument lists, drawings, specifications, and submittals to ensure quality, accuracy, and completeness.
  • Performing field walk downs to ensure installation meets design requirements.
  • Identifying deficiencies during installation and commissioning and ensure correction in a timely manner.
  • Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures.
Requirements:
  • BS Engineering or related discipline.
  • Minimum 8 years C&Q experience in facility and equipment C&Q in the pharmaceutical, medical device and/or biotechnology industry is required.
  • Strong utility and facility commissioning, qualification and validation experience.
  • Experience with FDA compliance and cGMP is required.
  • Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices, and procedures in a cGMP environment.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
  • Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative, and business integrity.
  • Excellent verbal, oral, and technical writing communication skills.
  • Proficient in Microsoft Word, Excel, Power Point, Project and able to quickly learn new computer applications.


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