Job Title:   Validation Engineer - (JP9556)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Pivotal AS
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 12/09/2021
Notes:

3 Key Consulting is hiring an Associate Scientist for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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. Works under immediate supervision. Reports to a manager.

Why is the Position Open?
Planned Project.

Top Must Have Skills:

• Experience with qualifying analytical laboratory computer instrumentation systems. Validations including leading, developing and implementing validation strategies and authoring required validation documents. (eg HPLCs, Spectrophotometers, FTIRs, etc.)
• Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
• Team player and independent working. Excellent communication.

Day to Day Responsibilities:

• Implement and coordinate the installation and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) 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 (i.e. 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 testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
• Support installation and requalification activities when needed to ensure proper systems startup, troubleshooting during use and recommend changes to improve system design.
• Work collaboratively across functions including Quality, IS, vendors and scientific lab staff.

Employee Value Proposition:
The person in this role will increase their experience with different type of analytical instruments and COTS validation

Red Flags:
Unclear communication, negative attitude, no experience with qualifications or validations, no experience with any analytical equipment, not familiar with drafting documents, not familiar with software permissions/configurations

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.