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C&Q Engineer
PSC Biotech
Melbourne, AUS
Contract
Senior · 5+ years experience
Onsite
Discovered 2 weeks ago
GMPFATSATSOPsDQIQ
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GMPFATSATSOPsDQIQ
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Requirements
- Requirements:
- Bachelor Degree in Engineering, Science, or a related discipline.
- 5+ years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
- Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach.
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPS, final reports and validation & quality policies.
- Understanding, developing, executing and maintaining CQV procedures and policies.
- Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo.
- Experience performing temperature mapping and qualification of benchtop autoclaves.
- Experience with digital validation platforms, preferably Kneat .
About PSC Biotech
BiotechnologyFounded 1996
Provides regulatory, quality, and engineering consulting services for life sciences.
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