Process Validation Engineer

5 days ago

Round Lake, United States Ventura Solutions LLC Full time
Job DescriptionJob Description

We currently have an opportunity for a Process Validation Engineer on a contract basis. The ideal candidate will have a background in the medical device or pharmaceutical industry, with experience in process validation, statistical analysis, equipment validation, and report writing.

Responsibilities

  • Plan, execute, and document process validation activities to ensure manufacturing processes are efficient, reproducible, and meet all quality standards.
  • Utilize statistical tools to analyze process data, identify trends, and drive continuous improvement.
  • Conduct validation of manufacturing equipment, including fill form seal and other related machinery, to ensure consistent and reliable operation.
  • Prepare detailed validation reports, protocols, and documentation in accordance with regulatory requirements and company standards.
  • Ensure all validation activities comply with relevant industry regulations, standards, and guidelines.
  • Work closely with R&D, Quality Assurance, and Production teams to ensure seamless integration of validation activities into the manufacturing process.
  • Identify and resolve process-related issues, providing technical support and recommendations for improvements.

Qualifications

  • Bachelor's or Master's degree in Engineering with 10+ years of experience in manufacturing medical devices, drug delivery devices, and/or combination products.
  • Proficient in statistical analysis and tools (e.g., Minitab, SAS).
  • Strong understanding of manufacturing equipment validation, including fill form seal machinery.
  • Experience with validation protocols, IQ/OQ/PQ processes, and risk assessment.
  • In-depth knowledge of regulatory requirements and standards (e.g., FDA, ISO 13485, cGMP).
  • Excellent written and verbal communication skills, with the ability to write comprehensive validation reports and documentation.
  • Strong analytical and problem-solving skills, with a proactive approach to identifying and addressing process issues.
  • Ability to work effectively in a cross-functional team environment.
  • Ability to work on multiple subjects concurrently and manage competing priorities effectively.

Key Leadership Competencies

  • Strong Communication Skills.
  • Builds strong relationships with peers and cross-functionally with partners to enable higher performance.
  • Strong leadership, negotiation, interpersonal, communication, and facilitation skills.
  • Learns fast, grasps the "essence" and can change course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Proven ability to succeed in a fast-paced, challenging, and complex environment.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  • Strong interpersonal and communication skills with demonstrated ability to work within a team environment.

Location

  • Round Lake, IL

Employee Type

  • W2

Benefits

  • Choice of medical dental and vision plans
  • Paid Vacation Time
  • Competitive base salary
  • 401(k)

This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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