o Determination of process validation/verification remediation required against Corporate SOP for Validations.
o Development of Project Plans to validate and/or Verify production processes. Identification of resource requirements & timing.
o Review of process documentation (SOP's, Work Instructions, Workmanship standards, Finished Goods & Product Specifications) for elements requiring remediation through validation and/or verification.
o Provide input to process FMEA's where appropriate.
o Analyse process data and determine capability of all processes through CpK & PpK statistical measures. Assignment and measurement of corrective actions to improve process capability.
o Initiating, approving & conducting process changes through change control system.
o Responsible for the Development of Master Validation Plans (MVP) for Process Validation. Writing & approval of Process Master Validation (MVR) Reports.
o Writing, conducting & Reporting on all Process Validation through OQ's, Process & Product PQ's. Performing of validation functional testing where appropriate.
o Provide technical input to development of Process Verifications Protocols, Studies & Reports
o Liase with other Departments.
o Generate validation documentation including pre and post approval (DQ/FAT/IQ/OQ/PQ/PPQ/FMEA)
o Ensure all data, results and info is recorded correctly.
o Assist in execution of validation protocols.
o Ideally will possess Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
o 4-6 years experience in a manufacturing environment with process and/or equipment validation. Ideally have validation experience through DQ, IQ, OQ, PQ etc.
o Strong Project Management experience & leadership skills.
o Experience in Biotechnology or Medical Device industry is required.
o Excellent problem solving skills.
o Excellent interpersonal, communication & report writing skills
o Flexibility with regard to hours of work and travel (will be minimum).
o Experience in process and automation validation ideal.
o Experience in mixing/cleaning/software validation an advantage.
DPS Biometics Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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