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Process Engineer III
2 months ago
We are seeking a highly skilled Process Engineer III to join our team at The Chemical Engineer. As a key member of our Technical Operations department, you will play a critical role in establishing, coordinating, and implementing key technical support activities to ensure the smooth operation of our processing, packaging, and maintenance departments.
Key Responsibilities:
- Technology Transfer: Responsible for transferring and launching new products to our site, including process scale-up and optimization.
- Quality Issue Investigation: Investigate quality issues, including system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR), and recommend corrective actions.
- Root Cause Analysis: Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department.
- Technical Document Generation: Generate technical documents, including protocols, reports, proposals, gap/risk assessments, batch records, and URS.
- Change Control: Generate, assess, and approve change controls.
- Quality Improvement Meetings: Attend Quality Improvement meetings and contribute to the development of quality improvement initiatives.
- Project Coordination: Assist in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC), and Commercial Operations.
- Process Execution: Support the Technical Operations team with process execution/equipment trials and design and acquisition of equipment.
- Batch Analysis: Perform batch analysis and provide recommendations for process improvements.
- Client Interaction: Interact with clients daily and provide excellent customer service.
- Team Collaboration: Work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities.
- Training and Development: Provide training/support to Co-Ops/Interns and monitor ongoing training.
- Safety and Compliance: Maintain a safe working environment and report potential hazards.
Requirements:
- Education: Post-secondary diploma in Chemistry, Engineering, Science, or related field. BSc in Chemistry or Engineering is an asset.
- Experience: Minimum 6 years of combined hands-on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids). Minimum 3 years of experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry.
- Skills and Abilities: Familiarity with pharmaceutical regulations (FDA, ICH, ISPE, and best industrial practices). Thorough knowledge of processing/packaging equipment. Thorough knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
Benefits:
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
