CQV / Validation Engineer
| Job Type | Permanent |
| Location | Massachusetts |
| Area | USA, USA |
| Market | Life SciencesLife Sciences - ConstructionLife Sciences - Engineering |
| Salary | $75,000 - $110,000 |
| Currency | USD |
| Start Date | |
| Advertiser | Courtney Robb |
| Job Ref | MK-951 |
- Description
What's the opportunity?
How does joining a Life Sciences engineering and consulting firm who are employee focused sound?
We are working with an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries across the US & Canadian markets. Their services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
They are looking to hire talented and passionate individuals to join their team!
How will you be challenged?- Execute IC/OC commissioning protocols for fermenters and the CIP skid
- Troubleshoot and resolve all commissioning issues
- Generate the commissioning summary reports for all respective protocols.
- Generation of the qualification protocols for the fermenters & CIP skids.
- Execute IQ/OQ qualification protocols.
- Troubleshoot and resolve all qualification issues
- Generate the qualification summary reports for all respective protocols.
- Assist or generate the CIP and SIP cycle development protocols and
- Execute the CIP and SIP cycle development protocols.
- Resolve all issues encountered
- Generate the required subsequent reports.
- Assist in the generation of the required PQ protocols
- Execute the PQ protocols.
- Resolve all issues encountered and generate the required subsequent reports
What does your background look like?
- Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree. 2-10 years of experience in the biotech-pharmaceutical academic or industrial environment.
- Basic knowledge of fermenters and unit-operations of fermenters
- Basic knowledge of cycle development for CIP and SIP
- Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations.
- Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
- Basic knowledge of the Commissioning and Qualification.
- Basic knowledge of using a Kaye validator
**Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply. Accepting US Citizens and Green Card Holders.**
asdf
