Process Engineer III
1 month ago
We are seeking a highly skilled Process Engineering III to join our team at Thermo Fisher Scientific. In this role, you will be responsible for establishing, coordinating, and implementing key technical support activities to Operations departments, including Processing, Packaging, and Maintenance. You will also support the Pharmaceutical Development Services (PDS) Process Development departments with new products that will be produced commercially at the site.
Key Responsibilities- Technology Transfer: Responsible for transfers and launches to the site, including process scale-up and process optimization.
- Investigate Quality Issues: Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department.
- Generate Technical Documents: Generate protocols, reports, proposals, gap/risk assessments, batch records, URS, and other technical documents.
- Generate, Assess, and Approve Change Controls.
- Attend Quality Improvement Meetings.
- Assist in the Coordination of Project Information between Account Management, Quality Assurance (QA), Quality Control (QC), and Commercial Operations.
- Support Technical Operations Team with Process Execution/Equipment Trials and design and acquisition of equipment.
- Perform Batch Analysis.
- Attend Key Project Team Meetings, Client Teleconferences and on-site visits. Interact with clients daily.
- Work Closely with Technical Writers and Production Supervisory Staff to ensure timely completion of Commercial manufacturing activities and attends weekly scheduling meetings (if applicable).
- Provide Training/Support to Co-Ops/Interns and monitor ongoing training (if applicable).
- Maintain a Safe Working Environment and report potential hazards.
- Perform Alternating and Rotating Shift Work (as required).
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, including proven abilities in report writing and batch record preparation required. Previous experience in statistical analysis and data compilation. Previous experience with SAP enterprise software to source information and navigate business operations. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and AbilitiesFamiliarity 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. Possess a highly developed quality, regulatory, and production mindset with an appreciation for client service and the contract manufacturing industry. Strong written and oral skills. Detail-oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills and communication skills. Ability to multi-task, meeting tight deadlines in a fast-paced environment. Proven problem-solving abilities. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Standards and Expectations- Follow all Environmental Health & Safety Policies and Procedures.
- Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives.
- Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP).
- Maintain workspace in a clean and orderly fashion.
- Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
- Be client and patient conscious at all times.
- Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem-solving.
- Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.
- Proactively identify areas for improvement in the execution of procedures.
- Communicate risks to timelines in a proactive manner.
- Consistently strive to improve skills and knowledge in related fields.
Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation, including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes, or odors, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective Equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.
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