Validation Engineer

PSC Biotech

Posted on: May 13, 2022

Closing: June 12, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

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.

We are hiring a mid-level Validation Engineer to support equipment validation, SIP, CIP, Media Fill, Filter Validation, and Packaging Validation.

 

Responsibilities

  • Assist all Installation Qualification, Performance Qualification, and Operational Qualification
  • Performs testing using standard concepts, practices, and procedures of the CGMP process
  • Prepare and maintain testing equipment
  • Draft, review, execute, and ensure accuracy in all required validation reports/documentation (final reports, SOPs, Validation Plans, Risk Assessments, Summary Reports, User Requirement Specification, etc.)
  • Perform and analyze validation risk assessment; provide effective troubleshooting and analysis for improvement where needed
  • Clearly communicate all progress, updates, and action steps
  • Ensure compliance with safety and quality standards

 

Requirements

 
  • 3-6 years of equipment validation, process validation, and/ or remediation experience in a cGMP regulated industry
  • Extensive knowledge of validation concepts
  • IQ, OQ, PQ, experience
  • Excellent technical writing skills
  • Experienced writing and executing effective validation plans, SOPs, risk assessments, summary reports, and final reports
  • Understands current risk-based validation approaches
  • Thorough knowledge of cGMP guidelines
  • Strong analytical and problem-solving skills

 

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

PSC Biotech

Posted on: May 13, 2022

Closing: June 12, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Admin, Operations, Quality

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