Ref No.: 18-06028
Location: South San Francisco, California
Job Title: Validation Engineer I
Job Location: South San Francisco, CA
Job Duration: 1 Year+

Responsibilities:
  • This position is for a Validation Contractor in South San Francisco Production (SSFP). The candidate will be responsible for supporting validation activities.
  • This work will include but is no limited to Cleaning Validation activities, qualifying new equipment or processes, qualifying changes to equipment, and revalidation activities.
  • Activities may include but are not limited to protocol generation, execution of protocols, data analysis, deviation intiation and investigation support, and summary report authoring.
  • The candidate will be expected to work effectively with customers (System Owner and Technical SME and Quality) to complete these validation activities.
  • Candidate must follow all safe work practices including use of appropriate Personal Protective Equipment. Typical schedule is Monday - Friday day time, however weekend and off shift work may be required.
Experience:
  • The candidate must have work experience in a GMP regulated environment and a good understanding of validation processes.
  • Also, the candidate must have equipment qualification or revalidation experience, Kaye Validator experience is preferred.
  • The candidate must have a passion for customer service to the diverse cGMP manufacturing customers and quality organization.
  • Knowledge and application of basic validation and risk management theories, principles and techniques used in biopharmaceutical manufacturing is required.
  • The candidate must be highly self-motivated, have excellent organization and communication skills, be willing and able to work independently and as part of a multi-disciplinary team.
  • The candidate must be comfortable with change and be willing to establish and work towards the future vision for the organization.