The Role
Perform commissioning, qualification, and validation (IOQ, PQ, functional tests) of manufacturing and laboratory equipment; author and review technical documents and reports; manage quality systems (deviations, change control) and maintenance documentation (PMs, work orders, job plans); ensure process and cleaning validation documentation is reviewed and approved.
Summary Generated by Built In
- Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test).
- In addition to Technical Writing, Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge.
- Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.
Requirements
- Doctorate OR Masters + 2 years of directly related experience OR
- Bachelors + 4 years of directly related experience OR
- Associates + 8 years of directly related experience OR
- High school/GED + 10 years of directly related experience.
Skills Required
- Experience with commissioning and qualification of manufacturing and laboratory equipment (IOQ, PQ, Functional Test).
- Experience in process and cleaning validation and review/approval of technical reports, procedures, and forms.
- Knowledge of Quality Systems including Deviations and Change Control.
- Maintenance documentation experience: preventive maintenance (PM), work orders, job plans review and approval.
- Technical writing experience for validation and qualification documentation.
- Education/experience: Doctorate OR Masters + 2 years OR Bachelors + 4 years OR Associates + 8 years OR High School/GED + 10 years of directly related experience.
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
