Hyde EC Job - 33349796 | CareerArc
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Company: Hyde EC
Location: Emeryville, CA
Career Level: Mid-Senior Level
Industries: Business Services, Consulting

Description

The CQ Utilities Lead Consultant will be responsible for the support and management of the commissioning and qualification projects.  The ideal candidate will be comfortable scoping projects, and have experience managing internal and external teams, while executing all comprehensive commissioning activities.  Example of utilities include:  WFI and Clean Steam, formulation, piping, process gasses, air flow automated inspection, and CIP systems. 

Responsibilities:

  • Has a functional relationship with Engineering, Project Controls, Finance, CM and CQV personnel
  • Must be capable of authoring and executing DQ/FAT/SAT/CTP/IQ/OQ/PQ/PV documents, developing SOPs, final reports and author/adhere to validation and quality policies/procedures/guidelines
  • Generate Verification Project Plans, System Impact Assessments, and Risk Assessments.
  • Approve air and water systems balancing by spot testing and by reviewing completed reports and by selected site observation.
  • The successful candidate will be comfortable dealing with a variety of project team members with different stakes in the project, including design engineers and architects, construction managers, contractors, and facility managers.
  • Witness HVAC piping pressure test and flushing, sufficient to be confident that proper procedures were followed.
  • Responsible for tracking documents, progress and projections, and initial review of documents prior to client review.
  • Analyze functional performance trend logs and monitoring data to verify performance.
  • Perform functional testing, including operating the system and components through each of the written sequences of operation, and other significant modes and sequences, including startup, shutdown, unoccupied mode, manual mode, staging, miscellaneous alarms, power failure, security alarm when impacted and interlocks with other systems or equipment.

Requirements:

  • 10+ years of relevant work experience in CQV role in the pharmaceutical or biotechnological industry
  • Experience with CQV of Facilities, Utilities, and Process Equipment
  • Must be thoroughly familiar with cGMPs and pharmaceutical and biopharmaceutical unit operations.
  • Strong track record in startup projects
  • Experience in one or more of the following; Clean & Black Utilities, Process Equipment, Freezers, Autoclaves, Warehousing, HVAC, E&I
  • Knowledge of the latest developments in the C&Q field and relevant legislation and industry standards (cGMP)
  • Committed, flexible, creative, assertive, communicative, motivated and well-organized.
  • Team player with a capacity to function in an independent role
  • Ability to build strong client trust and maintain client focus.

Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent—men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits.

You will find the following values reflected in our company:

  • Family
  • Integrity
  • Respect
  • Wisdom
  • Adventure
Hyde E+C is an equal opportunity employer.
 


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