Sr. Validation Engineer

Job title:                             Sr. Validation Engineer

Department / Division:      Quality Assurance - Validation

Salary Range:                      $100k - $130k per year, plus bonus

Location:                            Ada, MI

What do we need:

We are seeking an experienced Validation Engineer that has is interested in working across the life cycle of consumable products.  We are seeking team members who have a deep understanding of equipment qualification, process validation, and/or cleaning/sanitizing validation.  Our team is looking for someone who can collaborate across multiple functions, problem-solve, and advocate for the resolution of issues early.  This position will have responsibility across a range of production areas and equipment types, working in our Nutrition plants.

Your ability to work collaboratively and problem-solve will be valued in this role as you work broadly with many internal and external partners.  You will use a broad application of validation practices and principles to ensure studies are designed and executed with quality in mind.  You will have the opportunity to manage, lead, and/or participate in complex cross-functional efforts to improve product quality or processes.

Your initial focus will be supporting the influx of new equipment and new products.  This will entail authoring and overseeing equipment qualification, process validation, and cleaning/sanitizing validation studies.  Your expertise in these areas will drive best practices and appropriate risk-taking to ensure studies are efficient and effective.

In this role you will collaboratively or independently provide solutions to a wide range of difficult technical issues.  You will also have the opportunity to learn or use your past experience to execute a broad range of quality functions, including:

• Lead strategic quality improvement initiatives and teams or participates as QA lead for cross-functional initiatives including but not limited to equipment qualification, validation, value chain projects and new product launches
• Develop and review validation program to ensure sophisticated processes and equipment operate to produce quality products consistently
• Investigate out of specification results encountered during qualification or validation studies.  Work with cross-functional partners to identify and implement corrective actions.
• Interface with manufacturing, process engineering, product development, and regulatory representatives concerning deviations or issues; ensure effective corrective action is implemented as appropriate.
•   Represent customer to resolve quality issues encountered during validation studies.
• Ensure that products, materials and services comply with established specifications and technical requirements through application of quality tools and principles
• Lead and facilitate uniform standards globally - for both product standards and validation best practices
• Provide mentoring, coaching and support on technical programs and projects which may include directing the day-to-day work of technicians, lower level scientists/engineers, interns and/or contractors

Required qualifications:

• Minimum of 6 years of experience in validation, process engineering, plant engineering, manufacturing, and/or Quality Assurance in the CPG, food, or pharmaceutical industry
• Minimum of 3 years of experience specifically focused in one or more of the following areas:
  • Process/packaging validation
  • Cleaning and sanitizing validation
  • Equipment qualification (IQ/OQ/PQ)
• Demonstrated experience in Design for Quality or experience in product or process development is preferred
• BS degree in Chemical Engineering, Mechanical Engineering, Packaging Engineering, or a related field.

Preferred Additional Experience:

• Experience in root cause investigations and/or product development
• Experience in or supporting a GMP manufacturing environment 
• Experience with quality standards and Design for Quality practices
• Experience with data analysis, statistical techniques, and problem-solving

Skills to be successful in the role:

• Ability to collaborate with manufacturing, product development, global engineering, and operations engineering to effectively and efficiently resolve issues

This role is "Not" eligible for sponsorship.

What's special about this team:

The Validation team sits within the Nutrition Quality Engineering Department, which is a hardworking team of over 25 engineers across two Amway sites (Ada, Michigan and Buena Park, California).  The team works in a fast-paced environment supporting internal and external manufacturing sites to ensure quality product is produced and supplied to our customers.  Our team works heavily with cross functional partners such as engineering, product development, planning, suppliers, and manufacturing to prevent and address product quality issues.  Our team also works with our global QA counterparts in over 10 markets across many countries.  There is an ongoing shift from back-end to front-end design for quality work to get ahead of issues and minimize reactive quality work.  

This role is "Not" eligible for sponsorship.

#LI-TS1