PSC Biotech-posted 2 months ago
$85,000 - $100,000/Yr
CA
51-100 employees

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. With 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 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.

  • Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment.
  • Write and review technical documentation including specifications (URS, FS, DS), SOPs, risk assessments, and final reports.
  • Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
  • Conduct impact, gap, and risk assessments to identify potential issues and implement mitigation strategies.
  • Analyze test data and acceptance criteria to ensure accuracy and compliance.
  • Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications.
  • Ensure all validation activities meet current industry standards and regulatory requirements (cGMP, FDA, etc.).
  • Additional responsibilities as needed to support project deliverables.
  • Bachelor’s degree in Engineering or a related technical field.
  • 2 – 7 years of hands-on experience commissioning, qualifying, and validating process equipment within the pharmaceutical manufacturing industry.
  • Experience qualifying cleanroom facilities.
  • Experience in large process equipment in pharmaceutical manufacturing (vessels, centrifuges, filter presses and CIP skids).
  • Experienced writing and generating technical validation documentation including final summary reports, IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc.
  • Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.).
  • Strong understanding of risk-based validation approach.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to manage multiple projects and work both independently and collaboratively.
  • Ability to work extended hours.
  • Willingness and ability to travel as needed for project assignments and client engagements.
  • Ability to adapt to different locations, cultures, and work environments.
  • Salary bracket for this role is set between $85,000 - $100,000 annually, adjusted based on qualifications, skills, and professional experience.
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