Job Description:
Client is looking for a Validation Engineer with experience working on equipment qualifications for automation lines and lyophilizes (They have a Vendor that will execute the IOQ but would like to have someone oversee).
Job duties:
- Support equipment/process requirements, develop test protocols, lead pFMEA generation and effectively document results through the validation report.
- Coordinate with Suppliers to create validation/material qualification requirements, review, and approve final reports.
- Perform periodic review for equipment and processes to ensure the equipment of processes is still maintained at validated state.
- Responsible for initiating Engineering Change Control.
- Create project timelines for validations/material qualifications that include risk mitigations to achieve required timelines.
- Work with the Quality organization to optimize preventative maintenance and calibration process based on the validation requirements/plan.
- Utilize statistical tools, such as MiniTab, to determine whether the systems, process or materials meet requirements.
- Ability to identify root cause of failures or deviations to plan and come up with corrective actions.
- Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
- Strong ability to do root-cause problem solving, and implementation of effective preventative action.
- Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.
Qualifications:
- Bachelor’s Degree in Mechanical, Electrical, Chemistry, Biology, and/or Physics with 7+ years of experience in a manufacturing environment.
- Manufacturing experience is required.
- Periodic Reviews for equipment
- Manufacturing equipment including Fill / Pack and Lyophilizer (Freeze-Dryer) validation experience is required.
- Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries.
- Candidate must possess flexibility and agility to respond to constantly changing conditions and priorities.
- Must be willing to quickly learn and become proficient in common systems used to manage the business – to include production schedule, quality deviations, ERP system, and change control.
CA: Validation Engineer (236898)
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