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
Demonstrated ability to apply the following behavioral competencies on the job:
- 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
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