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Pharmaceutical Validation Consultant
2 months ago
Hughes Consulting, A Salas O'Brien Company is a dynamic and rapidly expanding organization dedicated to Process Engineering, Project Engineering, Project Management, and CQV (Commissioning, Qualification & Validation) solutions tailored for the pharmaceutical sector. We provide excellent benefits and present exciting opportunities for professional growth and personal leadership development.
Core Values & Company Culture:
- Professionalism is our standard.
- Integrity and Trustworthiness guide our actions.
- Open Communication is essential.
- Teamwork is at the heart of our success.
- We strive for Excellence in all endeavors.
- Safety is a priority in our workplace.
Current Opportunity:
We are actively seeking Validation Engineers with expertise in clean and dirty utilities within a pharmaceutical or biotechnology manufacturing context to contribute to upcoming CQV projects.
Eligibility Requirements:
- Must be authorized to work for any employer in the U.S. Sponsorship for employment visas is not available at this time.
Key Responsibilities:
- Play a pivotal role in the successful 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 facilities, including both equipment and utilities.
- Oversee the validation plan by reviewing documentation, protocols, procedures, and execution strategies, while coordinating with vendors and team members.
- Review and create essential documentation such as FAT/SAT, IQ/OQ & PQ protocols, User Requirements Specifications, Design documents, SOPs, and Risk Assessments.
- Engage in investigations and remediation efforts related to quality control activities involving 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.
- Understanding 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 needed.
Why Join Hughes Consulting?
- Experience high growth potential in a fast-paced, people-oriented 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 holidays.
- Utilize paid parental leave.
- Engage in leadership development training, career planning, and tuition reimbursement.
- Join in team social activities that foster a fun work environment.
- Receive recognition for your contributions.
- Work with an engaged and experienced leadership team.
About Us:
Hughes Consulting is built on the principles of individual leadership, with over twenty-five years of experience serving the pharmaceutical industry. Our mission is to provide top-tier engineering services and project management while upholding our core leadership values. We prioritize both personal and technical development for all associates through our comprehensive leadership and technical training programs.
*Hughes Consulting is an equal opportunity employer. We do not accept staffing support from recruitment agencies or similar services.*
