We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices.  With unique food science expertise and proprietary processes, we’ve pioneered many firsts.  Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula! 

The Cleaning Validation Engineer is responsible for the site’s equipment cleaning validation program. This position creates cleaning cycle development strategies for a variety of equipment including process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities to ensure all equipment and facilities are properly clean and in compliance with cGMP, FDA regulations, and SOPs.

Essential Duties and Responsibilities

• Develop and implement equipment/facility cleaning validation program.
• Create change controls for cleaning processes and/or equipment changes.
• Write and distribute validation protocols and risk assessments related to specific projects and facilities.
• Author and implement standard operating procedures (SOPs) to ensure compliance with cGMP and FDA requirements.
• Analyze the results of testing, determine their adequacy against predetermined standards, and make adjustments where needed.
• Investigate and troubleshoot problems which occur during cleaning.
• Lead the resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
• Perform cleaning studies, spray coverage testing, cleaning verification swabbing, risk sampling, risk assessment, and gap analysis for site cleaning programs to confirm efficacy of cleaning processes.
• Lead continuous improvement activities related to cleaning and changeover optimization.
• Identify appropriate facility cleaning/sanitizing agents; participate in cleaning/sanitizing effectiveness studies.
• Facilitate the development of user requirement specifications and operational SOPs for equipment.
• Adhere to strict documentation practices, reviews, and approvals.

Required Qualifications

Education and Experience:

• Bachelor’s degree in engineering or a related field.
• 5 years’ relevant work experience in an FDA-regulated industry.
• Experience supporting/executing installation & operation qualification (IOQ) of equipment related to various cleaning processes and activities.

Knowledge, Skills, & Abilities (KSAs):

• Thorough knowledge of cGMP/FDA regulations and cleaning validation requirements, practices, and procedures.
• Working knowledge of reviewing and writing technical documents, risk assessment reports, validation documents, IOQ protocols, and final reports.
• Working knowledge of quality management systems (QMS) for pharmaceutical or over the counter (OTC) operations.
• Strong leadership, analytical, organization, prioritization, multi-tasking, time-management, and detail orientation skills.
• Comfortable working in both a cross-functional/matrixed team environment and independently.
• Able to adapt to changing procedures and environment.
• Ability to drive change, influence, and motivate others toward a common vision.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
• Must be able to demonstrate practical problem solving and trouble shooting skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Preferred Qualifications

• Master’s degree or relevant professional certification.
• Experience in Cleaning Validation in an FDA regulated industry.
• Experience executing cleaning validation documents.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities