Validation Engineer

Company: PSC Biotech
Location: Carlsbad
Posted on: January 24, 2025

Job Description:

Carlsbad, United States - Posted on 10/17/2024PSC 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 ExperienceWith operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together to form something truly special. When you decide 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 RoleWe are hiring an experienced Validation Engineer. Successful candidates will be proactive, motivated, and capable of taking initiative to ensure the highest standards of quality and compliance.

• Lead and execute validation activities for equipment commissioning, qualification, and validation, facility and new product build-outs.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and quality standards.
• Develop, implement, and execute validation protocols (IQ, OQ, PQ) for required equipment and systems.
• Conduct system and impact assessments to determine validation requirements.
• Author and review user requirements specifications (URS) and other required validation documentation.
• Manage change controls to ensure compliance with regulatory requirements.
• Conduct risk analyses, and implement improvement strategy and corrective and preventative actions.
• Generate and manage required technical documentation including protocols, reports, etc.
• Additional responsibilities as required.Requirements
  • Bachelors degree or higher in related engineering discipline.
  • Minimum of 5 years of experience in commissioning, qualification, and validation engineering in the pharma/life science industry.
  • Experience with new product build-outs.
  • Strong understanding of industry regulations and compliance (cGMP, FDA, etc.)
  • Proven experience in risk and change control management.
  • Experienced writing, developing, and executing IQ, OQ, PQ protocols.
  • Experience in system and impact assessment.
  • Strong understanding of engineering specifications (URS, FS, DS, etc.)
  • Project Management capabilities.
  • Experience with clean-room qualification and environmental monitoring is a plus.
  • Experience with MasterControl is a plus.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proactive, motivated, and able to take initiative.
  • Willingness to travel as needed for project assignments and client engagements.Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
    • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
    • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
    • 401(k) and 401(k) matching.
    • PTO, Sick Time, and Paid Holidays.
    • Education Assistance.
    • Pet Insurance.
    • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms).
    • Financial Perks and Discounts.Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 - $140,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.Equal Opportunity Employment StatementPSC 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.
      #J-18808-Ljbffr

Keywords: PSC Biotech, Los Angeles , Validation Engineer, Engineering , Carlsbad, California