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Validation Engineer

1 month ago

Lufkin, United States PSC Biotech Full time
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it's about more than just a job-it's about your career and your future.

Your Role

We are hiring a motivated Validation Engineer to support multiple commissioning, qualification, and validation projects.

  • Assist in the development and execution of validation protocols (IQ/OQ/PQ) for equipment and processes.
  • Prepare and maintain comprehensive validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs).
  • Conduct validation testing and sampling, collect data, and perform data analysis to ensure compliance with regulatory standards.
  • Collaborate with cross functional teams to ensure alignment and successful completion of validation activities and deliverables.
  • Ensure all validation activities comply with current Good Manufacturing Practices (cGMP), FDA, EMA, and other relevant regulations.
  • Support continuous improvement initiatives by identifying areas for improvement in validation practices and processes.
  • Additional responsibilities as required to drive successful project completion.
Requirements
  • Bachelor's degree in relevant engineering discipline.
  • 2-4 years of experience in validation or a related field in the pharmaceutical or biotech industry. Internships or co-op experiences are highly desirable.
  • Basic knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
  • Knowledge of validation principles and methodologies.
  • Experienced in drafting, developing, reviewing, and authoring technical documentation including protocols, procedures, risk assessment, specification requirements, etc.
  • Hands-on experience with testing equipment, environmental monitoring equipment, and testing kits.
  • Detail-oriented with a focus on accuracy and compliance.
  • Excellent communication and interpersonal skills.
  • Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
  • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

Equal Opportunity Employment Statement:

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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