PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.

Responsibilities

• Write Process, Cleaning, Sterilization, Equipment and Software qualification protocols for various equipment such as Autoclaves, Depyrogenation Ovens, Lyophilizers, Filling Equipment, Environmental Chamber and Clean Utilities, to meet project deadlines
  
• Conduct statistical analysis of validation test results
  
• Perform testing and write reports for executed protocols
  
• Investigation/ troubleshooting of validation problems
  
• Interacts with ALL departments
  

Requirements

        Engineering/science bachelor's degree with 3-5 years of experience in validation

• 5 years' experience in pharmaceutical manufacturing or quality a real plus
  
• Innovative and capable of developing alternative solutions to issues at hand
  
• Knowledge of cGMP and general knowledge of associated industry and regulatory guidance documents (FDA/EU Guidelines, PDA Tech. Monographs, ISPE, etc.)
  
• Knowledge/understanding of protocol acceptance criteria and can readily identify protocol discrepancies and report them to management in a timely manner
  
• Ability to read/interpret engineering drawings and design documents
  
• Sound working knowledge of various processing equipment, for example (but not limited to) the following:  lyophilizers, washers, sterilizers, depyrogenation ovens, incubators, HVAC systems, freezers, refrigerators, fillers, formulation mixing systems, cleaning (CIP & COP) equipment
  
• Experience with Kaye Validator 2000 system (including report generation)
  
• Excellent technical writing, verbal communication, and presentation skills
  
• Must be people oriented and a team player
  
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio
  
• General knowledge of PLC/software validation
  
• Ability to gown and work in an ISO-5 environment is preferred

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 - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
  
• PTO, Sick Time, and Paid Holidays 
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at 24 Hour Fitness
  
• Financial Perks and Discounts

To apply, please visit our career site at https://careers.biotech.com/jobs/Careers/474128000044441023/Validation-Engineer?source=CareerSite