What are the responsibilities and job description for the Sr. Specialist, Validation Engineer position at IntePros?
IntePros is currently looking for a Sr. Specialist, Validation Engineer to join one of our growing Medical Device/Manufacturing clients in Tempe, AZ. The Sr. Specialist, Validation Engineer will report to the Program Validation Manager. In this role, you will support NPI projects with key focus around customer specification, Validation Master Plan, protocols, and reports. Provide the company with the technical and Validation resource to manage the Validation deliverables on selected NPI projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Sr. Specialist, Validation Engineer Responsibilities
Physical and Mental Requirements:
Sr. Specialist, Validation Engineer 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.
- 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.
- 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.
Physical and Mental Requirements:
- Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
- 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.