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Location

Pomona, CA | United States

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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 multicultural 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 Validation Engineer to join our team in Pomona CA. Candidates should have extensive technical writing experience as well as the review and execution of validation protocols. Equipment experience should include vial washers depyrogentation tunnels isolators and sterile fillers.

• Develop comprehensive validation protocols and plans ensuring compliance with industry regulations.
• Write review and execute validation protocols including IQ OQ PQ and so on for a range of equipment including but not limited to vial washers depyrogentation tunnels isolators and sterile fillers.
  
• Perform risk assessment identifying potential validation issues and implementing efficient mitigation strategies.
  
• Implement riskbased approaches to validation to optimize efficiency.
  
• Analyze validation data prepare reports and provide recommendations for continuous improvement.
  
• Collaborate closely with cross functional teams to ensure successful validation project completion.
  
• Maintain accurate and detailed documentation throughout the validation lifecycle including summary reports protocols master plans SOPs etc.
  
• Additional responsibilities as required.

Requirements

• Bachelors degree in related engineering discipline.
  
• 710 years of Validation Engineering experience within the pharmaceutical manufacturing industry.
  
• Advanced experience developing and reviewing technical validation documentation.
  
• Strong understanding of regulatory requirements.
  
• Direct and proven experience executing the validation and qualification for a range of equipment.
  
• Direct experience with vial washers depyrogentation tunnels isolators and sterile fillers.
  
• Excellent analytical and problemsolving skills.
  
• Excellent communication skills.
  
• 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) $130000 $150000

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 employersponsored 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.

#LITW1

Bachelor\'s degree in related engineering discipline. 7-10 years of Validation Engineering experience within the pharmaceutical manufacturing industry. Advanced experience developing and reviewing technical validation documentation. Strong understanding of regulatory requirements. Direct and proven experience executing the validation and qualification for a range of equipment. Direct experience with vial washers, depyrogentation tunnels, isolators, and sterile fillers. Excellent analytical and problem-solving skills. Excellent communication skills. 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.

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