Validation Specialist II
Validation Specialist II
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Salary Not Disclosed
1 Vacancy
Job Description
- Previous experience in CQV field or equivalent combination of education and experience.
- Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
- Areas of experience: Shipping Validation.
- This is a program lead role and will include status tracking of all projects periodic reporting of the status of all projects to leadership supporting design of transport qualification strategies reviewing and approving transport validation deliverables and accountability for on-time delivery of all transport qualification milestones.
- Well-developed communication skills both verbal and written.
- Years of Experience: 3 - 6 Years.
- This project support to be the lead point of contact for the shipping validation program.
- This will include tracking the status of all projects the periodic reporting of the status of all projects to management supporting design of transport qualification strategies reviewing and approving transport validation deliverables and accountability for on-time delivery of transport qualification.
- Very good possibility of Extension.
- No OT or weekends required.
- No exposure to chemicals.
- Free Parking onsite.
- Role will report to 2 sites 11 Forbes Northborough MA as needed but rarely.
- Must have reliable transportation.
- Lifting temperature-controlled environments cold room at times.
- PPE is required glasses vest personal protective equipment (PPE) protocol generation execution and closure.
- Bachelors degree in engineering (BSc/BEng) or related scientific discipline or an equivalent combination of education and experience.
- 3 6 years of experience within the pharmaceutical/biopharmaceutical industry - related to shipping validation.
- Familiar life cycle documentation.
- IQ/OQ/PQ installation qualification operational and performance qualification.
- Demonstrated expertise in shipping/transport validation processes.
- Experience with logistics customs international shipments/ cold chain experience.
- Risk assessment protocol generation execution and closure.
- Experience KNEAT (computer system a plus).
Employment Type
Full-time
