Quality engineer
Pharmaceutical Quality Engineer Senior
Major responsibilities include but are not limited to :
Perform Product and Process Trending, author reports and present at management review meetings.
Perform trending of all environmental monitoring and process utility data author quarterly reports and escalate any issues or adverse trends to Senior Management.
Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel.
Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management
Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, event assessment and trending is complete and accurate.
Update Quality Assurance standard operating procedures as required
Perform Gap assessments of corporate standards and guidance documents where required.
Perform other Quality related tasks such as deviation investigations and GEMBA assessments when required
Participate in programs for process improvements when required.
Basic Qualifications :
Bachelor's Degree and 5-10 years of relevant experience in Process trending and statistical control
Preferred Qualifications :
Ability to multitask.
Ability to work independently
Ability to interact and present information to upper level management
Working knowledge of Word, Excel, Minitab, PowerPoint or other data management applications
Ability to establish and maintain highly effective relationships with individuals from all levels of the organization.
Pilot Plant Senior Engineer
Role is on-site
Pay Rate -
Strategy & Organizational Development :
Ensures equipment operates to required HSE, Quality, Environmental and Reliability standards
Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)
Support internal and external audits
Implement GOPs
If needed, create regional / site SOPs & templates
Train operators and / or technicians
Maintenance & Calibration :
Execute maintenance improvement projects and initiatives (local or corporate)
Lead and execute Decommissioning activities for the engineering team
Establish cost efficient repair and maintenance processes in compliance with local regulations, HSE, GMP
Establish / coordinate maintenance & calibration plan content
Enter master data into CMMS (e.g. confirmation and technician time allocations)
Coordinate maintenance / calibration activities
Plan resources for maintenance / calibration
Allocate work for maintenance / calibration to technicians
Contribute to Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)
Enter work orders into CMMS for maintenance / calibration
Develop method statement for maintenance / calibration
Perform risk assessment for maintenance / calibration
Provide frontline support for technicians
Supervise maintenance / calibration work
Assess quality impact and release after maintenance
Assess equipment fit for purpose
Set-up maintenance for new equipment (incl. spare part needs)
Develop, monitor and improve KPI for maintenance & calibration
Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)
Manage technical / engineering changes : originate Change Request, approve Change Request, close Change Request
Investigate deviations (Root Cause Analysis)
Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation)
Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)
Vendor & Contractor Management :
Establish or contribute to vendor contract
Project Engineering & Control :
Identify technical solutions
Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)
Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project
Develop project turn over plan
Perform new equipment FAT / SAT / inspections in project
Perform commission activities
Manage project deficiencies and deviations
Perform provisional and final project handover
Re-) Qualification : MODULAR Content for discipline SME
Provide technical trouble shooting during PQ and validation
Develop periodic requalification plan
Execute periodic requalification plan