Senior Engineering Manager / Engineering Manager

Senior Engineering Manager/Engineering Manager

Company: Skingenix, Inc. – Job Location: Ontario, California

Company Description:

Skingenix Inc., a leader in dermal regeneration technologies, is located in Ontario, California. As an Innovative and mission-driven company, Skingenix pursues a standard of excellence in the regenerative medical industry with an emphasis on developing organ in-situ regenerative products for improving human health and quality of life.

Position Overview Statement:

Assist in the management of a new cGMP pharmaceutical facility construction, and purchasing process, installation and commissioning of the required process equipment and support utilities. Plan and execute validation of the facilities, equipment and utilities. Assist in producing the clinical and commercial materials. Supervise the maintenance of the facilities, equipment and utilities.

Primary Job Duties and Responsibilities:

  • Assist in evaluating and selecting engineering firms for construction of cGMP facilities, and installation of process equipment and support utilities
  • Assist in selecting, procuring and installing the process equipment and support utilities
  • Write the required procedures, protocols and reports to validate and maintain the facilities, equipment and utilities
  • Coordinate and direct engineering projects, making detailed plans to accomplish goals
  • Ensure that the compliance systems are robust and all engineering activities are well documented to meet with any internal and external audit requirements
  • Work with the Head of Manufacturing and Operations to ensure that cost effective and value added solutions are put in place to meet business needs
  • Develop and maintain the required engineering drawings
  • Recruit, as needed and approved, and develop new staff for the department in line with company procedures and standards
  • Work on other projects as assigned

Job Requirements:

  • Minimum Bachelor’s degree in engineering or bioengineering field
  • 8+ years of increasingly responsible experience in cGMP environment, including 5+ years of experience successfully managing construction, engineering and validation projects
  • Require working knowledge of Microsoft Suite and AutoCAD software for engineering drawings
  • Excellent verbal and written communication skills
  • Good planning, organizing, leadership and problem solving skills
  • Ability to travel within USA and outside USA (<20%)