IntePros · 23 hours ago
Sr. Specialist, Validation Engineer
Tempe, AZ
Full-time
Onsite
Senior Level
5+ years expIntePros is currently looking for a Sr. Specialist, Validation Engineer to join one of their growing Medical Device/Manufacturing clients. In this role, you will support NPI projects focusing on validation deliverables and coordinate activities to ensure timely closure of validation activities on projects.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Support the validation effort for all Strategic Projects on site
Chair, schedule, and minute validation meetings and participate in meetings when required
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
Generating, communicating, and updating Validation document tracker
Manage the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl
Lead equipment process and / or Design FMEAs
Leading 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 e.g. Ppk's, Cpk's, FOT/FAT visual inspections
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
Lead 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 e.g., Sampling data, project protocols and reports
Other duties as assigned
Qualification
Required
Third level qualification, at a minimum to degree level, in Engineering/Quality or Science
Must have a minimum of 5 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector
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
Demonstrated ability to lead, influence and train others
Must be able to work in a fast-paced environment
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated
Must have excellent communication skills both oral and written
Must be able to prioritize and organize tasks appropriately
Preferred
An excellent 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
Able to comply with the company's quality policy at all times
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
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