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Validation Engineering Associate
Posted 2 months ago
About the role
- Validation Specialist focusing on validation activities for biomanufacturing processes. Collaborating with various departments to ensure compliance with manufacturing standards and protocols.
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
- Develop effective ways to monitor product performance and analyze data
- Generate, execute and review qualification and validation studies according to approved protocols and SOPs
- Write protocol documents and reports for validation
- Analyze testing results and determine their acceptability
- Adhere to strict documentation, reviews and approvals
- Investigate and troubleshoot problems and determine solutions
Requirements
- 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
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