Validation Engineer Senior

Thousand Oaks, CA 91320

Posted: 05/22/2023 Job Number: 37455

Job Description


Pay range is $45 - $52 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

 

Validation Engineer Senior


Description:

ONSITE - THOUSAND OAKS HYBRID- PERSON WILL BE ONSITE 2-3 TIMES A WEEK AND NEEDS TO BE LOCAL
  • Primarily responsible for ensuring adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments.
  • Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries.
  • Provides guidance and sets standards in producing quality documentation, serves as the liaison between department, IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in issue resolution during installation and qualification activities.
  • Ability to effectively communicate and multitask.
  • Has knowledge of commonly used concepts, practices, and procedures within a particular field.
  • Relies on instructions and pre-established guidelines to perform the functions of the job; possess the ability to effectively communicate and multitask.
  • Works under immediate supervision with the ability to work independently and as a team.

Top 3 Must Have Skill Sets:    

CLEAR COMMUNICATION IS A MUST. CANDIDATE NEEDS TO BE FULLY FAMILAR WITH DATA INTEGRITY AND SOFTWARE VALIDATIONS (THIS NEEDS TO BE PRESENTED CLEARLY IN THE RESUME)

IS BACKGROUND PREFERRED (TECHNICAL SKILL) SEE BELOW
  1. Experience with qualifying analytical laboratory computer instrumentation systems. Validation actions including but not limited to leading, developing and implementing strategies and authoring required COTS Validation documents. (LCMS, FTIRs, Titrators etc.)
  2. Knowledge of cGMPs, ALOCA+, Data Integrity requirements (21 CFR Part 210/211, Part 11) and Analytical Instrument Qualifications (USP 1058).
  3. Team player and independent working with excellent communication.

Red Flags:    
  • Unclear communication. Unfamiliar with analytical instruments. Unfamiliar with data integrity/21CFR Part 11 requirements.
Day to Day Responsibilities:    
  • Implement and coordinate the installation and qualification of laboratory equipment and computer systems (hardware, software, and accessory systems etc.) for use in regulated operations.
  • Author qualification of CSV documents through system life cycle as outlined in applicable SOPs. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, testing summary reporting, and support documentation (traceability matrices, deviations, SOP, etc.). Manage documentation from creation to approval.
  • Review laboratory requirements and define procedures for instrument and data management/data integrity for new instrumentation.
  • Implement 21 CFR Part 11 for new and existing equipment, testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with company standards and cGMP requirements.
  • Support installation and re-qualification activities when needed to ensure proper systems startup, troubleshooting during use and recommend changes to improve application software’s system design.
  • Work collaboratively across functions including Quality, IS, vendors and scientific lab staff.

Meet Your Recruiter

Scott Brasel

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