PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up.
PharmEng Technology has offices in various locations including Canada, America and Asia. We've got projects across Canada, USA, Europe and Asia.
Roles and Responsibilities:
- Develop and execute validation protocols (IQ/OQ/PQ).
- Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
- Communicate effectively within PharmEng and with Clients, both orally and in writing.
- Appraise PharmEng management and the Client of the project progress.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
- Perform administration, monitoring, troubleshooting and upgrades to the corporate File, Printing, Internet access, Web and E-mail services.
- Develop SOPs and training manuals. Conducting validation activities at client sites.
- Recommend ways to improve organizational effectiveness for the Client if required and contribute to PharmEng Quality Team.
- Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP). Complete assigned projects and tasks within agreed deadlines.
- Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance
- Bachelor's or Masters Degree in Electrical Engineering or Computer Science and have a minimum of two years experience in pharmaceutical industry - production, packaging and labeling, laboratory, engineering or IT.
- Working knowledge of regulations (cGMP -- FDA 21CFR Part 11, Good Automated Manufacturing Practice (GAMP4), GLP and Good Automated Laboratory Practice (GALP)) and current industry practices in hardware/software validation and computerized systems such as SAP, LIMS, automated DCS, BMS, Delta V etc.
- Excellent communication skills both written and oral
- Organizational and technical skills with problem solving ability is a must.
- Willingness to travel
- Holds a valid driving license and passport
- Must be able to legally work in Canada and USA.
Please visit www.pharmeng.com for information in how to apply!
Thank you for your interest in our organization. However, only those selected will be contacted for an interview.