Devops engineer h1.location_city

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
Our Validation Engineers support the full system lifecycle management, ensuring analytical equipment and systems are implemented, validated, and maintained in compliance with FDA, EU, and global GxP regulations. This position plays a critical role in reducing compliance risks and enhancing operational performance while executing high-quality validation deliverables, providing technical expertise, and supporting regulatory readiness.

• Execute CQV lifecycle activities for analytical equipment and systems.
  
• Develop and execute required lifecycle documentation and deliverables, including but not limited to plans, requirement specification, risk assessments, traceability matrices, IQ/OQ/PQ protocols, summary reports, and change control documentation.
  
• Analyze testing data, verify data, and monitor results. Provide effective data integrity oversight.
  
• Participate in deviation investigations, root cause analysis, change control management, CAPA implementation, and risk-based impact assessments.
  
• Support new technology implementation, collaborating with cross-functional teams to establish and define requirements, operational practices, reliability, and compliance risks.
  
• Additional responsibilities as required.
  

Requirements

• Degree in Engineering, Life Sciences, or a related discipline.
  
• 5+ years of proven CQV experience within GxP regulated manufacturing and operations environments.
  
• Well-versed in analytical equipment and systems commissioning, qualification, and validation activities and system lifecycle management.
  
• Strong understanding of risk-based validation.
  
• Well-versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP, etc.)
  
• Experienced with traceability, change control, deviation handling, and CAPA management.
  
• Excellent documentation and writing skills.
  
• Strong communication skills and ability to work with cross-functional teams.
  
• Advanced analytical skills with strong attention to detail and commitment to quality.
  
• Must be authorized to work in the US.
  
• No C2C at this time.
  

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, 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 California's law on salary transparency, the salary bracket for this role is set between $100,000 - $120,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech 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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