Validation Engineer

3 weeks ago

Austin, United States PSC Biotech Full time
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 multicultural 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 experienced validation engineers responsible for the commissioning qualification and validation for pharmaceutical facilities utilities and equipment. Our engineers play a critical role in driving project success while supporting validation planning development documentation and execution and ensuring regulatory standards and quality requirements are met.

This is a W2 Temp position at 13 months with potential for extension.
  • Develop and execute commissioning qualification and validation protocols for required equipment and systems.
  • Prepare and maintain comprehensive documentation including validation protocols plans reports and standard operating procedures.
  • Identify and assess risks associated with CQV activities and develop mitigation strategies.
  • Troubleshoot and resolve issues related to equipment and process performance.
  • Support environmental monitoring requirements and related performance qualifications.
  • Collaborative with crossfunctional teams to ensure alignment on CQV activities and project timelines.
  • Ensure compliance with regulatory requirements (FDA EMA etc.) and industry standards (GMP GAMP etc.).


Requirements
  • Bachelor s degree in Engineering Life Sciences or a related field.
  • 35 years of equipment commissioning qualification and validation engineering in the pharmaceutical and/or biotech industries.
  • Experienced with manufacturing process equipment and clean room environments.
  • Experienced executing EMPQ.
  • Strong knowledge of regulatory requirements and industry standards.
  • Experience with validation lifecycle management and riskbased approaches.
  • Excellent analytical and technical problem solving skills.
  • Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.)
  • Effective communication and interpersonal skills.
  • Proactive with strong organization time management and project management abilities.
  • Excellent attention to detail with commitment to quality and compliance.


BenefitsOur W2 Temp Positions include our medical and sick time benefits.

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 employersponsored 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.

#LIJL1

Bachelor s degree in Engineering, Life Sciences, or a related field. 3-5 years of equipment commissioning, qualification, and validation engineering in the pharmaceutical and/or biotech industries. Experienced with manufacturing process equipment and clean room environments. Experienced executing EMPQ. Strong knowledge of regulatory requirements and industry standards. Experience with validation lifecycle management and risk-based approaches. Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance.

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