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Process Engineer
hace 2 semanas
**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.
Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.
**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 a **PROCESS ENGINEER** for an immediate temporarily position in Melbourne, Australia.**
**Role Summary**
**Over 3 years of experience in the Pharmaceutical Companies is required.**
Will be hands on the cGMP activities related to** **manufacturing department**.**
**Responsibilities**
- Participate in start-up of new facility, equipment, and processes in manufacturing.
- 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.
Firm understanding of cGMP validation requirements / guidelines and familiarity with EMEA and FDA regulatory 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.
TECHNICAL SKILLS & COMPETENCIES
- Highly structured individual who can work with significant complexity and in the “grey space”.
- Strong knowledge of pharmaceutical manufacturing essential.
- Self-driven and works independently to achieve milestones & goals.
- Seeks help with scope when appropriate.
What we offer
- Competitive Salary.
- Opportunities working for a global company.
- Continuous Professional Improvement including, but not limited to, courses or seminars.
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community.
PharmEng Technology is proud to be an equal opportunity workplace.
