Validation Engineer - JP9556
Validation Engineer - JP9556
Posted on :
05-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-04-2025
Job Description
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 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. Reports to a manager.
Why is the Position Open
Planned Project.
Top Must Have Skills:
Day to Day Responsibilities:
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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
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 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. 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
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