CQV Engineer

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.

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.

CQV Engineers are responsible for supporting commissioning qualification and validation projects for pharmaceutical facilities utilities equipment and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients success.

• Assist in commissioning and startup of new equipment utilities and cleanroom systems during facility buildout.
  
• Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment.
  
• Prepare and maintain documentation including validation protocols plans reports and standard operating procedures.
  
• Support risk assessments and mitigation strategies related to CQV activities.
  
• Troubleshoot and assist in resolving issues related to equipment and process performance.
  
• Collaborate with cross-functional teams to align CQV activities with construction and project timelines.
  
• Coordinate with vendors and contractors to support hand-offs and system turnover.
  
• Ensure compliance with regulatory requirements (FDA EMA etc.) and industry standards (GMP GAMP etc.).
  
• Provide technical support during validation execution and qualification activities.
  
• Additional responsibilities as required.
  

Requirements

• Bachelor s degree in engineering or a related field.
  
• 5 years of commissioning qualification and validation engineering experience in the pharmaceutical and/or biotech industries.
  
• Proven experience supporting or leading CQV activities during new facility buildouts including equipment installation and startup.
  
• Strong background in cleanroom facilities process equipment and utility systems.
  
• Familiarity with project execution and project management tools.
  
• Deep understanding of regulatory requirements and industry standards (GMP GAMP FDA EMA).
  
• Knowledge of validation lifecycle and risk-based approaches.
  
• Excellent analytical and technical problem-solving skills.
  
• Strong technical writing skills and experience with validation documentation (protocols reports procedures etc.).
  
• Effective communication and interpersonal skills.
  
• Organized proactive and detail-oriented with a commitment to quality and compliance.
  
• Travel is required. At PSC Biotech many of our projects and clients are located in various regions around the country. We value candidates who are willing and able to travel as needed for project assignments and client engagements. Adaptability to different locations cultures and work environments is essential for successful collaboration.
  

Benefits

• 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
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts
  

Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $90000 $120000 annually. The offered salary may be adjusted based on various factors such as the applicants qualifications skills and professional experience.

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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