Software Validation Specialist Jobs in Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
Validation Engineering Associate
About the role
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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About Prollenium Medical Technologies Inc.
Prollenium Medical Technologies Inc. is a fast-growing Canadian manufacturer and distributor of premium HA dermal filler. We are proud to address all of our client's needs through streamlined medical device innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. US FDA, Health Canada, and CE approvals, over 4 million syringes in the Revanesse product line have been sold to 80+ countries world-wide.
Prollenium is the only manufacturer of Hyaluronic Acid dermal fillers in North America. Join our dedication to innovation.