Validation Engineering Associate
Prollenium Medical Technologies Inc.
Job Summary
The Validation Specialist supports the manufacturing team by performing process valuations on new and current manufacturing processes. This position reports to the Senior Director of Manufacturing.
Major Responsibilities
- Conduct validation, temperature mapping, and calibration activities
- Measure instruments, software performance and machine performance to determine operating as defined and required
- Establish and maintain methods to control the biomanufacturing processes and develop effective ways to monitor product performance, and analyze data
- Generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures)
- Write protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated
- Analyze the results of testing and determine their acceptability against predetermined criteria
- Adhere to strict documentation, reviews and approvals. Investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgrading equipment and software
Additional Responsibilities
- Provide validation related support to other departments and leaders
- Other duties as assigned
Minimum Qualifications
Technical Knowledge/Experience
- Bachelor's degree in science or engineering
- Knowledge of and experience with GMPs (Good Manufacturing Process).
- Knowledge of and experience with Validation programs, Installation qualification (IQ), Operational Qualification (OQ) Performance qualification (PQ)
- Knowledge of and experience with DOE (Design of Experiment)
- Knowledge of and experience with various statistical analysis and statistical tools
- Documented experience with technical report preparations in English
- Experience with problem solving skills, Gage R and R, cPK analysis, OEE, control charts. FMEA, Risk Analysis, CAPA
- Working knowledge of ISO 13485-2016, 21 CFR and various regulating agencies: Health Canada, FDA and EU
- Proficient command of the English language, both written and verbal
Behavioural
- Teamwork: Ability to work independently and effectively and productively with others
- Communication: Understand and follow verbal and written instructions
- Problem Solving: Anticipating, analyzing, diagnosing and resolving problems
- Organization and Planning: Utilizing logical, systemic and orderly procedures to meet objectives
- Flexibility: Ability in adapting to change
Vacancy posted 7 hours ago
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