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Validation Engineer

2 months ago

Raleigh, United States Hughes Engineering, PLLC Full time

Job Type

Full-time

Description

Hughes Engineering & 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 career development as well as 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 Engineering & Consulting is currently accepting applications for Validation Engineers with experience in clean and dirty utilities within a pharmaceutical or biotechnology manufacturing environment to support future CQV (Commissioning, Qualification & Validation) 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.

Validation Engineer Responsibilities:
  • Contribute directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols, change controls and reports for systems that may be complex in nature, to support client facilities.
  • Support start-up, commissioning, qualification, and validation activities for cGMP manufacturing facilities including equipment and utilities.
  • Control validation plan by reviewing documentation, protocols, procedures, and execution strategies, coordinating with vendors and team members.
  • Review and author related documentation including FAT/SAT, IQ/OQ & PQ protocols, User Requirements Specifications, Design, SOP's, and Risk Assessments
  • Participate in investigations and remediation of quality control activities with pharma equipment.
  • Maintain a safe and clean working environment by enforcing procedures, rules, and regulations.
You will have:
  • Bachelor's Degree in Engineering or related field (Chemical or Mechanical preferred)
  • 2 to 4 years of validation experience within a pharmaceutical, FDA or similiar regulated environment
  • Clean and/or dirty utilities experience
  • GMP/cGMP change control process experience.
  • Knowledge of industry regulated guidelines for the validation of cGMP facilities
  • Relevant experience within the Pharmaceutical or Biotechnology industries
  • Excellent verbal and written communication skills
  • Attention to detail
  • Technical documentation skills
Desired Skills:
  • Ability and willingness to travel
If you are qualified, have leadership potential and a willingness to learn, Hughes could be the right career choice for you

Why Hughes Engineering & 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 (We have fun)
  • Employee Recognition
  • Engaged and experienced Leadership Team

Hughes Engineering & Consulting is a licensed engineering consulting company 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 Engineering & 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 Engineering, PLLC is an equal opportunity employer. We are not accepting staffing support from recruitment agencies or similar services. *