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Validation Engineer III

BestCo

Location: Mooresville, North Carolina 28115
Type: Full-Time, Non-Remote
Posted on: August 25, 2022
This job is no longer available from the source.
Full-Time Plant Job Details Description BestCo Inc. is a privately-held manufacturer located and operated in Mooresville, North Carolina. BestCo is known industry-wide as a leading developer and marketer of innovative, consumer health care products for retailers and marketers of OTC drug products and dietary supplements. BestCo specializes 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.  BestCo combines nearly a century’s worth of confectionery experience with emerging consumer healthcare insights to create unique products for our customers.  BestCo strives to be a pioneer and innovator in the field of confectionery delivery forms of OTC drugs and dietary supplements. Check out our website at www.bestco.com or our social media pages on LinkedIn and Facebook BestCo is currently searching for a Validation Engineer III, to be located at our Mooresville, North Carolina facility. Position 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. 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 Supervisory Responsibility:This job will not have supervisory responsibilities. 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 Preferred Qualifications:• Experience working in MasterControl • Six Sigma Black or Green belt; ASQ or PMP certification All offers of employment are conditioned upon the successful completion of a background investigation, drug screen, and employment eligibility verification (E-verify).       Qualifications