Job title: Validation Engineer – Austin, TX (Onsite)
Company: SMART CALIBER TECHNOLOGY
Job description: Position: Validation Engineer IVLocation: Austin, TXDuration: 12 MonthsNOTE ~ FIRST COUPLE OF WEEKS HOURS WILL BE 8 AM TO 5 PM FOR TRAINING AND THEN WILL BE TRANSITIONED TO 2ND SHIFT HOURS OF 3 PM TO 11 PM. PLEASE BE SURE TO INFORM YOUR CANDIDATES.Manager is looking for a candidate who has “managed” validation efforts not just executed them.
- List 3-5 hard requirements for the role: Developing validation protocols (IQ/OQ/PQ/TMV), driving strategy to resolve unexpected results, driving validation strategy, Requirements development, experience with high-volume fully automated manufacturing lines.
- List any preferred requirements that would stand out on a resume: Developing validation protocols (IQ/OQ/PQ/TMV), driving strategy to resolve unexpected results, driving validation strategy, Requirements development, experience with high-volume fully automated manufacturing lines.
- Years’ of experience required: 7+ years of “Managing” validation efforts and projects.
- Required education level/certifications: Bachelors in Science or Engineering.
- Daily tasks/duties and department interactions: The items you submitted on the posting seem to fit here.
Main Responsibilities:Participate in the development or modification of validation packages and deliverables, including assessments, plans, requirements, and protocols.Report unexpected events or issues which occur during validation to project team and management.Apply sound, systematic problem-solving methodologies in identifying, investigating, assessing impact, and resolving unexpected events or issues which occur during validation.Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSes protocols, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements for multiple projectsDrive strategy of FUE & process validation for new or changing products, processes, facilities, equipment, etc.Ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment, system, process, and/or product implementations/changes.Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)Drive to meet validation schedule as aligned with project(s) goals.Works independently with objectives given by the Quality Manager.Plan and coordinate own work according to higher level project schedules.Performs other related duties and responsibilities, on occasion, as assigned.
- Monthly or quarterly metrics the candidate will be measured on: ability to support activities and timelines associated with validations for equipment upgrade projects
- Description of work environment/department: Quality
Best Regards,Chetna630-425-6471 -D815-600-8657-FaxTruth Lies in Heart
Expected salary:
Location: Austin, TX
Job date: Tue, 16 Jul 2024 22:07:04 GMT
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