Process Engineering II

Thermo Fisher Scientific•Mississauga, ON

19d

About The Position

Division/Site Specific Information: Our Mississauga facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in the same plant using scalable equipment for non-GMP and GMP work. Discover Impactful Work: Support the Technical Operations department in generation of protocols, master batch record review, batch analysis, Quality Investigation Report/Quality Deviation Report (QIR/QDR) follow-up, process execution and equipment procurement. Day in the Life: Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization. Investigate quality issues could include system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR). Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc). Generate technical documents (protocols, reports, proposals, gap/risk assessment, batch records, URS, etc). 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 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)

Requirements

Post-secondary diploma in Chemistry, Engineering, Science or related field. BSc in Chemistry or Engineering is an asset.
Minimum 3 years of experience within Pharmaceutical Manufacturing or Quality Assurance departments
Minimum 2 years of combined hands on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).
Minimum 1-year experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required
Knowledge of processing/packaging equipment.
Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
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.

Nice To Haves

BSc in Chemistry or Engineering is an asset.
Previous experience in statistical analysis and data compilation an asset.
Previous experience with SAP enterprise software to source information and navigate business operations an asset.

Responsibilities

Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization.
Investigate quality issues could include system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR). Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc).
Generate technical documents (protocols, reports, proposals, gap/risk assessment, batch records, URS, etc).
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 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)