Senior Validation Engineer, Biotech – Hybrid; JP

Position: Senior Validation Engineer, Biotech – Hybrid (JP11465)
Job Title:Senior Validation Engineer, Biotech – Hybrid (JP11465)
Location:Thousand Oaks, CA (Hybrid, twice a week on site)
Employment Type: Contract to Hire
Business Unit:Business and Operations Management
Duration:Initial 3 months with likely extension(s).
Posting Date:05/22/2023.
Rate
: $50-58 / Hour plus benefits.
Note:Onsite 2-3 times a week

3 Key Consulting is hiring aSenior Validation Engineer
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; 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:

• 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.)
• Knowledge of cGMPs, ALOCA+, Data Integrity requirements (21 CFR Part 210/211, Part 11) and Analytical Instrument Qualifications (USP 1058).
• Team player and independent working with excellent communication

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.

Red Flags:
Unclear communication. Unfamiliar with analytical instruments. Unfamiliar with data integrity/21

CFR Part 11 requirements.

Interview process:
1 Web Ex Interview

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role.
#J-18808-Ljbffr