Validation Engineer w/t SIP-CIP
Posted on :
13-10-2022
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Job Description
Responsibilities:
- The hiring manager needs a couple of resources to support their continuing monitoring/cleaning steaming program and needs a resource that is very strong in writing.
- The team got the go ahead from the VP to bring on a couple of contractors to help address their backlog in summary reports.
- It would be a huge bonus if they are strong in writing.
- This position is 100% onsite role.
- They will also be doing SIP validation on manufacturing equipment. CIP experience will also be a plus.
- Needs someone who can hit the ground running immediately. This will be on the floor doing a lot of execution work.
- If they have autoclave SIP experience it may work as well.
- SIP can only happen during breaks in manufacturing, which doesn't happen very often.
- Cleaning Val happens on a rolling basis. Therefore, would prefer someone that understands the concepts and rationale behind the way they do SIP over someone well versed in cleaning validation.
- Looking for people who can be on the floor executing studies. Prefer to have people to know more that can troubleshoot the equipment and be that eyes on the floor for the validation group.
- working on the backlog of validation summary reports.
- They will be working with the Cleaning Validation - Execution team. There is a paperwork aspect to it but it's primarily restricted to writing the protocols and writing the summary reports.
- Will be doing the execution of the SIP study
- writing the summary reports; Protocols and summary reports all have templates in place.
- potentially writing deviations, if the candidate is more tenured. These typically fall under validation related issues. Product Quality and Patient Implace deviations are handled by the FT QA staff.
- Specific experience
- Summary Reports
- SIP qualification
- CIP Experience
- SIP validation
- autoclave qualification
- autoclave validation
- kaye validators
Employment Type
Full Time
Key Skills
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