| Company: | Actalant |
|---|---|
| Job Role: | Validation Engineers |
| Experience: | 2-4 years |
| Vacancy: | 15+ |
| Qualification: | BE/BTech, ME/MTech, |
| Salary: | 80000 USD - 95000 USD/Year |
| Location: | Across USA |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
Job Title: Validation Engineer
Location: Cambridge, USA
Job Type: Full-time
About the Company:
Actalent is a leading talent solutions provider that offers scalable solutions and services to connect passion with purpose. Our team of experts provides exceptional services to help our clients achieve more and drive value and results. We are committed to promoting consultant care and engagement through continuous development experiences. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
Job Description:
Actalent is seeking an experienced Validation Engineer to perform validation activities in the media preparation, cell culture, utilities, and QC areas of a cGMP biotech manufacturing facility. The ideal candidate will have hands-on experience in executing installation, operational, and performance qualifications for equipment, facilities, utilities, cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols. The Validation Engineer will analyze validation results, compile data into reports, and generate custom validation protocols. Additionally, the candidate will play a lead role in the successful completion of project milestones and crucial technical tasks.
Key Responsibilities:
- Perform validation activities in the media preparation, cell culture, utilities, and QC areas of a cGMP biotech manufacturing facility.
- Execute Installation, Operational and Performance Qualifications for equipment, facilities, utilities, cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
- Analyze validation results and compile data into reports for initial qualifications and requalifications.
- Generate custom validation protocols and execute validation protocols.
- Play a lead role in the successful completion of project milestones and crucial technical tasks.
- Provide assistance with Calibration and Metrology liaison responsibilities as department needs require.
Required Skills and Qualifications:
- Bachelor's Degree or equivalent work experience and 3-4+ years of validation experience OR Master's Degree and 2-3+ years of validation experience.
- 3+ years of experience with process, equipment, utility, and/or software validation in a GMP regulated environment.
- Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
- Working knowledge of GMPs, temperature chamber, sterilization, cleaning, software, and depyrogenation qualifications.
- Writing validation protocols and final reports and managing validation projects.
Preferred Skills:
• PQ, OQ, IQ, Validation, GMP, equipment validation, software validation, and validation protocols.
Experience Level: Intermediate Level
Actalent is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
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