Validation Engineer

We are growing Come be apart of our success!This Jobot Job is hosted by: Kyle CherryAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $50,000 - $100,000 per year

A bit about us:Specializing in manufacturing solid dose lozenges, soft chews, and other confectionery-based delivery forms of consumer healthcare products for both private label and contract manufacturing partners.

Why join us?We offer competitive wages in addition to a comprehensive benefits package including a 401(k) with company match.

Job DetailsPosition Summary : The Validation Engineer provides oversite of the site facilities and engineering programs including systems commissioning, qualifications, and technical change control. This role is also engaged in the design, development, and coordination of Quality Improvement (QI) and Performance Improvement (PI) initiatives in support of superior quality and operational outcomes at the Company.Required Qualifications:

• Bachelor's degree in technical area (preferably Food Safety, Engineering or Science).
• 12+ years' experience in Quality Engineering, Control or Assurance in the nutraceutical, pharmaceutical, food or medical device industry.
• Demonstrated project management/leadership experience.
• 10 years' experience in systems qualification/validation.
• 8 years' experience with Six Sigma, QC/QA methodologies, tools, and processes.
• 8 years' experience working with FDA Regulations.
• Strong communication, organizational, teamwork, presentation, analytical, reporting and project management skills.
• Knowledge of statistical principles and analysis and failure investigation principles.
• Proficiency in Microsoft Office including Excel, Outlook, and PowerPoint.
• Working knowledge of GAMP5 compliance requirements
• Experience in overseeing and managing factory equipment calibrations

Essential Duties and Responsibilities:

• Provide oversite of facility projects, including installation and upgrading of equipment, to ensure site is maintained in a qualified state of operation.
• Act as a point of contact for all site qualification and validation activities including the review and approval of lifecycle documents such as IQ/OQ/PQ and validations.
• Review requirement specifications and technical documents and provide timely and meaningful feedback.
• Provide validation oversight of Technical Change Control for facilities and equipment changes.
• Lead the development and implementation of site qualification and validation processes in compliance with all applicable CFR regulations.
• Collaborate on design, development, and coordination of Quality Improvement and Performance Improvement initiatives. Interface with internal project teams and stakeholders.
• Effectively communicate relevant project information to the Leadership Team.
• Drive a systematic approach to problem solving and process improvement using quality management and engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiment, etc.
• Oversee CAPAs, Deviations, IRs, and audit action follow-ups across all technical teams.
• Assist in internal audits and external audits to support compliance.
• Train and mentor associates in validation principles.
• Oversee compliance to computerized systems and calibration systems for all factor

Preferred Qualifications:

• Experience working in MasterControl
• Six Sigma Black or Green belt; ASQ or PMP certification

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.