Validation Engineer JP9623
Validation Engineer JP9623
Posted on :
11-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title: Validation Engineer (JP9623
Location: Thousand Oaks CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/13/2022
Note: Onsite Essential
3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Summary:
Top Must have Skill Sets:
DayToDay Responsibilities:
Employee Value Proposition:
The person in this role will increase their experience with different type of analytical instruments and COTS validation
Red Flags:
Interview Process:
Video conference.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at other positions on our websitewww.3keyconsulting. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/13/2022
Note: Onsite Essential
3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Summary:
- 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 followthrough 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 preestablished guidelines to perform the functions of the job.
- Works under immediate supervision with the ability to work independently and as a team. Reports to a manager.
Top Must have Skill Sets:
- 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.
DayToDay 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:
- No experience with computerized analytical equipment.
- No experience with software permissions/configurations.
- No experience with drafting or reviewing documents.
- Unclear communication and not a team player.
- Unfamiliar with 21CFRPart11.
Interview Process:
Video conference.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at other positions on our websitewww.3keyconsulting. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
