Validation Engineer
IntePros is currently looking for a Validation Engineer to join one of our premier clients on a one year contract! The Validation Engineer will support new product introduction (NPI) projects with key focus around customer specification, Validation Master Plan, protocols and reports.
This person will provide the company with the technical and Validation resource to manage the Validation deliverables on selected Global Engineering projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Validation Engineer
Responsibilities:
Preparation, review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.
) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes in conjunction with program Quality representation.
Generation and review of the following documents:
VMP's Design Reviews (DR's) TM's Design Specifications (DS's) - FDS, VDS, SHDS, etc.
pFMEA and eFMEA's Engineering Studies (Process Development, DOE's, shrink studies, characterization studies, etc.
) Metrology Studies (GR&R, MSA Attribute Agreement, equivalency studies, etc.
) FAT protocols and reports SAT protocols and reports IQ protocols and reports OQ protocols and reports PQ protocols and reports DMR documentation (Preventative Maintenance/Installation/Operation/Setup WKI's, BHR's, QC's, etc.
) Generating, communicating and updating Validation document tracker.
Weekly team meetings to communicate risks, action items and decisions to cross functional teams.
Direct and support assisting tech writers in documentation feedback cycles and review meetings with approvers.
Review of specifications and drawings to translate to CTQ's for validation methodologies.
Review of third party generated protocols and reports in conjunction with program Quality representation.
Generation of validation documentation (protocols & reports) against the signed off VMP and customer requirements.
Ensure the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl.
Participate in the review and disposition of all attribute and variable data for the program against customer specification / drawing e.
g.
Analysing and reporting of key measures eg.
Ppk's, Cpk's, FOT/FAT visual inspections.
Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
Prepare data/presentations and attend review meetings with the customer.
Implement best practices principles into client QMS as applicable.
Support internal and supplier audits.
Trending and tracking of Validation data to drive improvements eg Sampling data, project protocols and reports.
Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all local site Environmental, Health and Safety regulations Compliance to all local site company policies, procedures and corporate policies.
Perform additional duties at the request of the direct supervisor.
Validation Engineer Basic
Qualifications:
Must have a third level qualification, at a minimum to degree level, and/or a Bachelor's degree in Engineering, Quality, or Science Must have a minimum of 3 years post graduate experience working in a high-volume manufacturing environment A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
Must have an in-depth knowledge of validations in a Medical Device environment.
Validation Engineer Preferred Knowledge, Skills and Abilities:
Good understanding of plastic process manufacturing.
Good understanding of computer system validation.
Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company's safety policy at all times.
Travel Requirements:
Must be able to travel up to 15% of the time.
Recommended Skills Auditing Automation Communication Conflict Management Filing Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
This person will provide the company with the technical and Validation resource to manage the Validation deliverables on selected Global Engineering projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Validation Engineer
Responsibilities:
Preparation, review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.
) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes in conjunction with program Quality representation.
Generation and review of the following documents:
VMP's Design Reviews (DR's) TM's Design Specifications (DS's) - FDS, VDS, SHDS, etc.
pFMEA and eFMEA's Engineering Studies (Process Development, DOE's, shrink studies, characterization studies, etc.
) Metrology Studies (GR&R, MSA Attribute Agreement, equivalency studies, etc.
) FAT protocols and reports SAT protocols and reports IQ protocols and reports OQ protocols and reports PQ protocols and reports DMR documentation (Preventative Maintenance/Installation/Operation/Setup WKI's, BHR's, QC's, etc.
) Generating, communicating and updating Validation document tracker.
Weekly team meetings to communicate risks, action items and decisions to cross functional teams.
Direct and support assisting tech writers in documentation feedback cycles and review meetings with approvers.
Review of specifications and drawings to translate to CTQ's for validation methodologies.
Review of third party generated protocols and reports in conjunction with program Quality representation.
Generation of validation documentation (protocols & reports) against the signed off VMP and customer requirements.
Ensure the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl.
Participate in the review and disposition of all attribute and variable data for the program against customer specification / drawing e.
g.
Analysing and reporting of key measures eg.
Ppk's, Cpk's, FOT/FAT visual inspections.
Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
Prepare data/presentations and attend review meetings with the customer.
Implement best practices principles into client QMS as applicable.
Support internal and supplier audits.
Trending and tracking of Validation data to drive improvements eg Sampling data, project protocols and reports.
Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all local site Environmental, Health and Safety regulations Compliance to all local site company policies, procedures and corporate policies.
Perform additional duties at the request of the direct supervisor.
Validation Engineer Basic
Qualifications:
Must have a third level qualification, at a minimum to degree level, and/or a Bachelor's degree in Engineering, Quality, or Science Must have a minimum of 3 years post graduate experience working in a high-volume manufacturing environment A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
Must have an in-depth knowledge of validations in a Medical Device environment.
Validation Engineer Preferred Knowledge, Skills and Abilities:
Good understanding of plastic process manufacturing.
Good understanding of computer system validation.
Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company's safety policy at all times.
Travel Requirements:
Must be able to travel up to 15% of the time.
Recommended Skills Auditing Automation Communication Conflict Management Filing Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
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