CQV Project Engineer

1 week ago

Los Angeles, United States Azzur Group Full time
Azzur Is a GxP Compliance And Consulting Organization Dedicated To Providing High Quality, Expertly Backed, Assistance That Drives Life Science Companies To Success. We Are Seeking Highly Motivated And Talented Individuals To Join Our Incredible Team Of Skilled Problem Solvers. Qualified Candidates Must Have a Desire To Learn, Apply, Engage, And Adapt In The Ever-changing Healthcare Field While Simultaneously And Organically Exuding Azzur’s Core Values

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun

Responsibilities

  • Develop and closeout change control documentation accommodating agreed changes to the design, in collaboration with the client Subject Matter Experts.
  • Support development of conceptual process designs and the corresponding process flow diagrams and piping/instrumentation diagrams.
  • Support development of design documents for the process equipment in accordance with Good Engineering Practice, i.e. URS, FRS, HDS, SDS, CS, etc.
  • Experience in executing FMEAs, system impact assessments (SIAs), and other applicable risk assessments (RAs).
  • Prepare detailed bid evaluations for procurement of the process equipment and system construction packages.
  • Support development of process equipment procurement specifications and data sheets based on approved design documents.
  • Manage and coordinate FATs and SATs.
  • Experience overseeing the qualification of building automation systems (BAS) and control systems (Siemens/Desigo, Delta V control system).
  • Manage all aspects of the Process Engineering function from concept to final qualification and system release, including project updates and maintaining process equipment project schedules.
  • Review vendor equipment drawings and specifications and drive the system integration with the site utilities and computerized systems (SCADA).

Essential Requirements

  • Education: BS/MS degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
  • 10-15 years’ experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
  • A minimum of 5 years of experience overseeing and implementing technical engineering projects is a requirement.
  • Experience with facilities, utilities, and process equipment. Examples include vessels, tanks, centrifuges, filter press, clean in place (CIP) systems, air handling units (AHU), reverse osmosis (RO), compressed gases, cooling water, and waste systems.

Ideal Project Leadership Qualities

  • Prior experience leading facility expansion projects, facility buildouts, and/or process development.
  • Provide technical leadership in deviation, out-of-specification, and change control management, ensuring compliance with internal standards and regulatory requirements.
  • Run technical meetings, develop action lists, and drive actions to completion.
  • Project planning and scheduling for Commissioning, Qualification, and Validation.
  • Progress measurement and reporting for Commissioning, Verification, and Validation.
  • Highly motivated and organized, solutions-oriented leader.
  • Able to produce results in a fast paced, collaborative environment.
  • Excellent facilitation, negotiation, conflict resolution skills, and cross functional collaboration skills to foster positive business relationships with the ability to network with different functional areas.
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast-paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Working for multiple clients throughout the region.

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