Quality Control Engineer

2 weeks ago

Columbia, South Carolina, United States Hughes Consulting, A Salas O'Brien Company Full time

Hughes Consulting, A Salas O'Brien Company is a dynamic and rapidly expanding organization specializing in Process Engineering, Project Engineering, Project Management, and CQV (Commissioning, Qualification & Validation) solutions tailored for the pharmaceutical sector. We provide exceptional benefits and present stimulating opportunities for both professional growth and personal leadership enhancement.

Core Values & Company Culture:

  • Professionalism is paramount.
  • Integrity and Trustworthiness guide our actions.
  • Effective Communication is essential.
  • Teamwork is at the heart of our success.
  • We strive for Excellence in all endeavors.
  • Safety is a priority.

Current Opportunity:

We are actively seeking Validation Engineers with expertise in clean and dirty utilities within a pharmaceutical or biotechnology manufacturing setting to contribute to upcoming CQV projects.

Key Responsibilities:

  • Play a vital role in the execution of validation projects by developing validation schedules, master plans, protocols, change controls, and comprehensive reports for complex systems to support client facilities.
  • Assist in the start-up, commissioning, qualification, and validation processes for cGMP manufacturing environments, including equipment and utilities.
  • Oversee the validation plan by reviewing documentation, protocols, procedures, and execution strategies, while coordinating with vendors and team members.
  • Review and author essential documentation such as FAT/SAT, IQ/OQ & PQ protocols, User Requirements Specifications, Design documents, SOPs, and Risk Assessments.
  • Engage in investigations and resolution of quality control issues related to pharmaceutical equipment.
  • Ensure a safe and orderly working environment by enforcing established procedures, rules, and regulations.

Qualifications:

  • Bachelor's Degree in Engineering or a related discipline (Chemical or Mechanical preferred).
  • 2 to 4 years of validation experience in a pharmaceutical, FDA, or similarly regulated environment.
  • Experience with clean and/or dirty utilities.
  • Familiarity with GMP/cGMP change control processes.
  • Knowledge of industry regulations concerning the validation of cGMP facilities.
  • Relevant experience in the Pharmaceutical or Biotechnology sectors.
  • Strong verbal and written communication skills.
  • Meticulous attention to detail.
  • Proficient technical documentation skills.

Preferred Skills:

  • Willingness and ability to travel as required.

Why Choose Hughes Consulting?

  • Join a high-growth, fast-paced organization with a people-centric culture.
  • Receive competitive compensation along with performance-based incentives.
  • Enjoy company-paid medical premiums for employee options.
  • Access to dental and vision insurance plans.
  • Benefit from company-paid life, short-term, and long-term disability insurance.
  • Participate in a Health Savings Account.
  • Contribute to a 401(k) Retirement Plan with employer contributions.
  • Take advantage of Paid Time Off (with rollover options) and Paid and Floating Holidays.
  • Utilize Paid Parental Leave.
  • Engage in leadership development training, career planning, and tuition reimbursement.
  • Participate in team social activities that foster a fun work environment.
  • Receive recognition for your contributions.
  • Work alongside an engaged and experienced leadership team.

Hughes Consulting is built on individual leadership principles, boasting over twenty-five years of experience in the pharmaceutical industry. Our mission is to deliver top-tier engineering services and project management while upholding our core leadership values. We emphasize both personal and technical development for all associates through our comprehensive training programs.

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

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