Jr Validation Engineer

Job Title:

Jr Validation Engineer

We are seeking a motivated entry level Validation Engineer to join our team. This role is open due to the retirement of a previous team member. The engineer will collaborate with R&D and compounding teams on process instructions, coordinate change controls across the plant, and draft cleaning or production protocols. The position involves direct communication with customers via email or teams, focusing on expanding our contract manufacturing customer base and developing new products.

The primary focus will be on change control and process validation.

• Exhibit qualities of cooperation and coordination; maintain professional interaction in all business contacts.
• Ensure consistent attendance and adherence to the work schedule.
• Comply with and enforce all company safety rules and procedures, and report safety issues.
• Coordinate validation activities and assist in maintaining the Validation Master Plans.
• Communicate project progress using project management tools and techniques effectively for multiple projects.
• Provide technical assistance and interface with other departments for validation requirements.
• Ensure GMP documentation complies with governmental regulations such as FDC.
• Monitor laws pertaining to the Food, Drugs, and Cosmetic Industries and advise management on validation issues.
• Define and improve systems and processes.
• Read and understand Piping and Instrumentation Diagrams and create Process Flow Diagrams.
• Develop process control procedures and automation specifications to ensure compliance with validation systems.
• Evaluate data from current processes to recommend improvements for cost-effectiveness and production quality.
• Utilize Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess systems and processes.
• Create or modify Standard Operating Procedures (SOPs) and work instructions, and recommend changes to batching instructions.
• Perform Statistical Process Analysis to evaluate process control.
• Conduct Site Acceptance Tests and Factory Acceptance Tests prior to equipment startup.
• Develop, implement, and maintain validation protocols for facility systems (IQ/OQ/PQ), processes (PV), and cleaning validations (CV).

• Bachelor's Degree in an Engineering field (mandatory per FDA requirements).
• Experience or exposure to change control and quality/equipment validations.
• Familiarity with pharmaceutical manufacturing, particularly in liquid fill operations.
• Knowledge of FDA and GMP regulations.
• Ability to read and understand CAD drawings and piping systems.

• Experience with validation protocols and working within a manufacturing environment.
• Understanding of the liquid fill process.
• Ability to think through controlled processes for consistent product quality.
• Experience with filtration, water pretreatment, reverse osmosis, CIP/SIP systems, steam, cooling water, batch mixing, and sanitary piping systems.

The role involves working in a manufacturing facility and an office/cubicle setting. The entry level Validation Engineer will collaborate with one senior validation engineer, a team of Quality Engineers, and designers. This position offers an opportunity to gain valuable experience in consumer goods and FDA/GMP regulations, learning from a tenured team in a manufacturing environment.

This is a Contract to Hire position based out of Saint Louis, MO.

The pay range for this position is $30.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance…