Validation Engineer

Location

Carlsbad, CA | United States

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

We are hiring an experienced and driven Validation Engineer to support commissioning and validation projects, as well as overall design support. 

• Develop, execute, and review validation protocols, ensuring compliance with regulatory requirements and industry standards.
• Support the development, writing, and review of specification documentation including URS, FS, and DS. 
• Develop and implement construction control plans, ensuring adherence to cGMP and regulatory requirements.
• Collaborate with the engineering team to provide validation input during the design phase of projects.
• Perform risk assessments and provide guidance to mitigate potential validation issues during construction.
• Validate utilities and process equipment to ensure they meet regulatory and company standards, including but not limited to lyophilizers, chrome skids, controlled temperature units, bioreactors, and so on. 
• Troubleshoot and resolve validation-related issues with utilities and equipment.
• Prepare and maintain comprehensive validation documentation, including protocols, change controls, reports, and standard operating procedures (SOPs).
• Conduct factory acceptance testing when required. 
• Additional responsibilities as required. 

Requirements

• Bachelors Degree in engineering or related. 
• 3-6 years of experience of validation, commissioning, and qualification engineering experience in the pharmaceutical manufacturing industry. 
• Proven experience and success in developing specification documentation including URS, FS, DS, etc.
• Background in supporting construction projects.
• Experienced conducting factory acceptance testing.
• Experienced in project design support, ensuring that validation considerations are integrated into the design and implementation of new systems and processes.
• Experienced with utilities and process equipment (lyophilizers, chrome skids, controlled temperature units, tanks, bioreactors, etc.) 
• Advanced knowledge of industry regulations. 
• Experience with automation controls is a plus.
• Excellent communication and collaboration skills.
• Detail-oriented with a focus on ensuring compliance and quality.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

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
  

Estimated Annual Salary (dependent on experience) $85,000 - $100,000. 

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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