- Title: Validation Engineer
- Code: RCI-9599912
- Location: Framingham Massachusetts (MA) 01701
- Posted Date: 12/03/2019
- Duration: 8 Months
Talk to our Recruiter
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
- Perform validation projects in a GMP biotech manufacturing facility.
- Develop/plan qualification/validation studies, execute, compile data, and author reports
- Resolve protocol nonconformances.
- Knowledge of risk-based validation approaches that meet current regulatory requirements, internal standards and industry practices.
- Complete all internal training.
- Demonstrated success working across organizations in highly matrixed/team environment.
- Proficient in use of GE/Kaye Validator as applicable.
- Experience with validation of GMP manufacturing equipment and utilities, e.g., WFI, compressed gases, HVAC, controlled temperature units
- Familiarity with applicable US and worldwide regulatory requirements.
- Ability to read/interpret engineering drawings and design documents..
- Excellent technical writing and verbal communication skills.
- Proficiency in Microsoft Office including Word and Excel
- Knowledge of Validation Lifecycle Approach.
- plus previous experience in CQV field or equivalent experience.
- Experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
- Areas of experience: CQV of GMP manufacturing equipment, including requalification.