More jobs:
Job Description & How to Apply Below
The main responsibility of these positions will be to support the recipe design process and maintain existing electronic batch records using Manufacturing Execution System at the Brampton site.
Duties & Responsibilities
Assist with drafting of process flow diagrams from paper-based master formulas for loading into MES.
Design and assist other designers in the team with filling out predefined templates with data collected from various sources.
Create Compounding Master Batch Records (MBRs) working in collaboration with Pharma Technology specialists.
Create Packaging Generic Master Batch Records (GMBRs) and Parameter Value Lists (PVLs) working in collaboration with QA Documentation specialists.
Support creation and maintenance of Master data, Library elements, EQM State diagrams etc. on an ongoing basis.
Support the creation and management of equipment state diagrams and equipment cleaning/calibration specifications (ESP).
Work with different types of MES PCS - SCADA, DCS and Historian.
Perform when required process measurements and analysis in support of process improvements and to identify core issues (Pareto Chart, Process Flowing Mapping, Time Studies).
Participate in coordinating system design, build, testing and validation for process improvement and GMP related software solutions.
Support testing activities by helping with recipe testing in development environment.
Assist with electronic recipe approvals, preparing and verifying Tractability Matrices between MES MBRs and Paper Master Formulas.
Execute tests and qualification protocols to support implementation of new systems and installations if required.
Provide adequate training to stakeholders pertaining to the implementation and use of MES.
Prepare reports, user and maintenance manuals, procedures, technical specifications, and qualification protocols.
Assist business technicians with shop floor support activities with regards to use of MES if required.
Refine training materials such as SOP’s, training manuals and other documents based on feedback from MES specialists from various departments.
Complete all GMP Documentation correctly and in a timely manner.
Complete all training assignments and maintain personal training records.
Initiate, and follow through with actions required to close Change Controls.
Other duties as assigned.
Additional Responsibility (Only Applicable To Customer Facing Roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day.
Qualifications
Recent graduate in an Engineering or Science (Computer, Chemistry etc.) discipline.
Solid knowledge of Manufacturing Execution Systems (MES). Werum PAS-X experience required with deep understanding or implementation skills.
Extensive Programming or computer logic knowledge/experience preferred.
Experience with documentation or technical writing.
Working knowledge of database fundamentals and ERP systems.
Knowledge of Process Control Systems and solid Project Management skills.
Strong engineering fundamentals and problem solving skills.
Strong listening skills and ability to pick-up details from documents.
Knowledge of process flow and logic diagrams/drawings.
Experience working with design or other software applications.
Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment.
Experience Working knowledge of Kepware’s KEPServerEX, and other OPC servers.
Ability to learn and utilize new software/ equipment to implement solutions.
Knowledge of Good Manufacturing Practices.
Working Conditions
Working in the office with immediate presence on the manufacturing shop floor as required for the support.
General working hours (9 a.m. to 5 p.m.), may be extended during time of training and special activities.
Flexibility to be at site and varying work schedules to implement CPI initiatives at a 24/7 site. Training assignments may involve working rotating shifts.
Ability to work under dynamic and evolving business objectives along with emerging constraints.
Physical Requirements
Office based
Compensation & Benefits
Base salary range: $57,000 to $71,000 (actual may vary). Salary may be modified. Eligible for Annual Performance Bonus Plan and employee benefit programs including medical, dental, vision coverage; life insurance; RRSP savings plan; employee assistance program; paid time off (vacation, sick time).
Equal Employment Opportunity
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.
#J-18808-Ljbffr
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
Search for further Jobs Here:
×