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Job Description
Our client is in need of a Senior CSV/CQV Consultant for a 3-month, on-site engagement at their Verona, WI facility.Document prep can be conducted off-site, CQV will require on-site support.Duties and responsibilities will include, but are not limited to:
- Commissioning of AHU’s, rooms, compressed and breathing air systems, and purified water
- Phase 1 Qualifying (DIOQ) of:
- WebCTRL
- Facility Qualification
- HVAC System
- Compressed and Breathing Air System
- Nitrogen System
- Purified Water
- Phase 2 Qualifying (PQ) of:
- WebCTRL
- Phase 3 Manufacturing equipment qualification including
- Kilo Hood
- Integrated Rotovap- 220 EX
- Process Isolators (several per room)
- Tray Dryer
- Huber TCU A - (Unistat 905W)
- Process Chiller - Delta T
- Glass Jacketed Reactors (several per room)
- Lyophilizer
- Freezer
- Refrigerator
Qualifications
- Qualified candidates will possess a Bachelor’s degree in related field along with 10plus years related industry experience.
- Candidates must have excellent verbal communication and technical writing skills.
- Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
- Familiarity with many aspects of validation is expected.
- Experience with temperature mapping.
- Proficient in Microsoft Word, Excel, Power Point and Project.
- Must be willing to travel regionally and/or nationally throughout the US.
Additional Information
Allcandidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.