Validation Specialist

2 weeks ago

Columbia, South Carolina, United States Hughes Consulting, A Salas O'Brien Company Full time
Job Title: Validation Engineer

Hughes Consulting, A Salas O'Brien Company is a dynamic and fast-growing organization focused on delivering exceptional engineering services and project management solutions to the pharmaceutical industry.

We are seeking a highly skilled Validation Engineer to join our team and contribute to the completion of validation projects. The ideal candidate will have experience in clean and/or dirty utilities within a pharmaceutical or biotechnology manufacturing environment.

Responsibilities:
  • Develop validation schedules, master plans, validation protocols, change controls, and reports for complex systems.
  • Support start-up, commissioning, qualification, and validation activities for cGMP manufacturing facilities, including equipment and utilities.
  • Control validation plans 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.
Requirements:
  • Bachelor's Degree in Engineering or related field (Chemical or Mechanical preferred).
  • 2 to 4 years of validation experience within a pharmaceutical, FDA, or similar 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.

We offer a competitive compensation package, including performance-based incentive programs, company-paid medical premiums, dental and vision insurance, and a 401(k) retirement plan. Our company culture emphasizes leadership development, career planning, and tuition reimbursement. We are an equal opportunity employer and do not accept staffing support from recruitment agencies or similar services.

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