Demo

Validation Engineer

Salas O'Brien Engineers Incorporated
Raleigh, NC Full Time
POSTED ON 2/20/2025
AVAILABLE BEFORE 4/17/2025

Job Details

About the job

Hughes Consulting, A Salas O'Brien Company 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 Validation 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.

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 combined validation experience with equipment, utilities or facilities within a cGMP or FDA regulated environment.
  • 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 Consulting?
  • High growth potential and fast paced organization with a people focused culture
  • Competitive pay plus performance-based incentive programs
  • Comprehensive Medical, Dental & Vision insurance plans.
  • Company paid Life, Short-Term, and Long-Term Disability insurances
  • Health Savings Account
  • 401(k) Retirement Plan (employer contribution)
  • Paid Holidays and Paid Time Off (PTO rollover option)
  • Leadership development training, career planning, and tuition reimbursement
  • Team Social Activities
  • Employee Recognition
  • Engaged and experienced Leadership Team

Hughes Consulting, A Salas O'Brien Company 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 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 or follow us on LinkedIn.

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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