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CQV Engineer

3 months ago

Raleigh, United States Hughes Engineering, PLLC. Full time
Job DescriptionJob DescriptionDescription:

Hughes Consulting is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career and personal leadership development


Company Culture Guidelines & Values:

  • We are Professional.
  • We are Trustworthy and have Integrity.
  • We Communicate.
  • We are a Team.
  • We pursue Excellence.
  • We are Safe.

Hughes Consulting is currently accepting applications for CQV Engineers with experience in either facilities, equipment or utilities validation within a pharmaceutical or biotechnology manufacturing environment to support future CQV (Commissioning, Qualification & Validation) activities to support future projects.


Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.


CQV Engineer Responsibilities:

  • Perform Commissioning, Qualification, Validation team activities.
  • Control CQV plan by reviewing documentation, protocols, procedures, and execution strategies, coordinating with vendors and team members.
  • Generate C&Q Procedures
  • Participate in the development of CQV Planning, ETOP and Documentation Reviews, Protocol Generation and Protocol Execution
  • Help develop Validation objectives by reviewing project proposals and plans, conferring with management.
  • Prepare validation reports by collecting, analyzing, and summarizing information during execution.
  • Work with startup teams during the commissioning and validation phases of a project, ensuring clear communication and hand-off of information.
  • Maintain a safe and clean working environment by enforcing procedures, rules, and regulations.

You will have:

  • Bachelor’s or Master's degree in Engineering or related field (Chemical, Mechanical or equivalent preferred)
  • Minimum 5 years of relevant work experience in Commissioning, Qualification and Validation of Equipment, Utilities or Facilities within a cGMP environment.
  • Strong understanding of commissioning activities
  • Proficiency in life sciences manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, critical utilities.
  • Knowledge of industry regulated guidelines for the validation of cGMP facilities
  • Excellent verbal and written communication skills
  • Technical Documentation Skills
  • Attention to detail

Desired Skills:

  • Ability and willingness to travel

If you are qualified, have leadership potential and a willingness to learn, Hughes Consulting could be the right career choice for you


Why Hughes Consulting?

  • High growth potential and fast paced organization with a people focused culture
  • Competitive pay plus performance-based incentive programs
  • Company paid Medical premiums for Employee option.
  • Dental & Vision insurances
  • Company paid Life, Short-Term, and Long-Term Disability insurances
  • Health Savings Account
  • 401(k) Retirement Plan (employer contribution)
  • Paid Time Off (rollover option) and Paid and Floating Holidays
  • Paid Parental Leave
  • Leadership development training, career planning, and tuition reimbursement
  • Team Social Activities
  • Employee Recognition
  • Engaged and experienced Leadership Team

Hughes Consulting was founded on individual leadership principles with over twenty-five years of experience serving the pharmaceutical industry. Our mission is to deliver best in class engineering services and project management without compromising our core leadership values. At Hughes Consulting, we emphasize both personal and technical development for all associates through our leadership and technical training programs. For more information about our company, please visit www.hugheseng.com or follow us on LinkedIn.


*Hughes Consulting is an equal opportunity employer. We are not accepting staffing support from recruitment agencies or similar services. *

Requirements: