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Sr. cGMP Quality Validation Engineer - PERM role w Biotech leader

MEDVACON

Sr. cGMP Quality Validation Engineer - PERM role w Biotech leader

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

    MEDVACON is working with our BIOTECH CLIENT LOCATED IN SAN DIEGO ON A KEY POSITION FOR A SENIOR QUALITY VALIDATION ENGINEER with a solid Biotech background. Our client is looking for a true blend of technical ability coupled with leadership and team building skills…someone ready for the next step in their career. 

    Responsibilities

    • Responsible for performing manufacturing processes validation, cleaning validation, and equipment validation. This includes developing validation master plans preparing protocols, analyzing test results, and preparing technical reports
    • Coordinates validation activities with, and seeks team support from, Project Management, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget
    • Review and approve proposed changes for products by performing risk assessments, providing guidance and support, and assessing the adequacy of verifications and validations
    • Maintains up-to-date knowledge of validation requirements, practices, and procedures across the industry
    • Mentor and coach engineering, manufacturing, and quality personnel on the best practices for validations
    • Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy, and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility, and education levels
    • Complies with Health, Safety and Environmental responsibilities applicable to the position
    • Manage validation records in an electronic database system
    • Support client audits as needed
    • Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
    • Perform other duties as assigned

    The company has been operating for more than 20 years and still seeing tremendous growth….Base, bonus & full benefit package including medical, dental, vision, LTD, and a retirement plan.    Countless employee recognition and incentive programs and events.  Truly a great place to work...

  • Qualifications

    Qualifications

    • BS Degree or equivalent in a scientific discipline.
    • Quality professional with a minimum of 8 years of relevant experience in a life science industry, 
    • Requires knowledge of FDA regulated biotechnology or drug validation requirements (e.g., 21 CFR 210, 211 or 21 CFR 820 or ICH Q7)
    • Experience executing validation projects for biotech production projects
    • Must have specific knowledge of validation methodologies and principles including Cleaning Validation.
    • Strong technical writing and analytical skills
    • Expertise in risk management and application of FMEAs to validations
    • Understand mRNA, pDNA manufacturing process a plus

    Additional Information

    NO! AGENCIES OR 3RD PARTY AGENCIES.  WE DO NOT WORK THROUGH OTHER EMPLOYERS

    THIS IS A POSITION directly with the client

    Please attach a WORD resume to your submission

    This is A FULL TIME POSITION W EXCELLENT BENEFITS

    The work is ON-SITE All of your information will be kept confidential according to EEO guidelines. EOE/Veteran/Disabled