Cgmp Process Operator

3 weeks ago

Toronto, Canada Pharmeng Technology Inc Full time

**PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.**

**PharmEng Technology** is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.**

**PharmEng Technology is seeking cGMP Process Operators for immediate position in Melbourne, Australia, willing to travel and work temporarily in Australia**

**Role Summary**

**Over 3 years of experience in the Pharmaceutical Companies is required.**
- ** Participate in start-up of new facility, equipment, and processes in manufacturing.**:

- ** Knowledge of Chromatography and Tangential Flow Filtration a plus but not mandatory**:

- ** Responsible for writing, executing, and summarizing efforts to develop equipment process parameters per the site SOPs, user requirements, and product needs.**:

- ** Assures professional and quality performance in all activities, meeting times, and cost and cGMP requirements.**:

- ** Adaptive and flexible to scheduling of engineering runs.**:

- ** Coordinates activities necessary to execute engineering study (lab support, commodities, etc.).**:

- ** Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc.).**:

- ** Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering, and validation to implement those changes.**:

- ** Coordinate activities with the automation team to resolve automation issues and changes.**:

- ** Coordinate activities with maintenance to resolve mechanical issues.**:

- ** Additional activities related to equipment Engineering Studies as determined by the team lead.**:

- ** Availability to relocate in Australia is a must.**

**Advanced knowledge of cGMP requirements for the Pharmaceutical/biopharmaceutical industry.**

**Proven capability to assess processes, equipment, and products for sources of variation, ability to analyse data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.**

**Experience with Microsoft Office Suite.

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