Validation Engineer

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Full Time Regular Professional Argentum Medical, Geneva, IL, US

Salary Range: $ To $ Annually

• Medical Device – preferably manufacturing over design
• Process/Equipment Validation
• Manufacturing
• Project Management
• Automation – Robotics & Manufacturing Cells
• Familiar with e‑QMS systems such as QT9

Oversees and executes design and process validation activities to ensure regulatory compliance and high quality production processes and products consistent with established standards by performing the following duties personally.

• Maintains quality assurance objectives complementary to corporate policies and goals.
• Participates in the Design and Development process.
• Leads and/or writes IQ, OQ, and PQ protocols for new and modified equipment and software.
• Leads and/or performs IQ, OQ, and PQ activities for new and modified equipment and software.
• Leads and/or writes IQ, OQ, and PQ reports.
• Assists Engineering with process development and engineering trials.
• Ability to lead others in writing technical documentation clearly and informatively.
• Lead a validation team.
• Lead Corrective and Preventive Actions, Complaint Investigations, Non‑Conformance investigations, and any required follow‑up actions relative to Validation.
• Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
• Provides leadership to technical and administrative workers engaged in quality assurance activities related to validation activities.
• Maintains a working knowledge of company quality assurance documents, instructions, and procedures.
• Leads quality management teams within the organization.
• Responsible for training personnel in processes related to validation activities.
• Leader in process and product improvement activities related to validation activities.

• Experience:
  
  Three years’ experience in validation activities in a medical device or pharmaceutical environment.
• Education:
  
  Bachelor’s degree or higher, preferably in a scientific field.
• Language Ability:
  Ability to read and interpret quality assurance and company procedures. Ability to communicate clearly and concisely, both verbally and in writing. Ability to effectively present information and respond to questions from employees, supervisors, managers, and executive staff.
• Math Ability:
  Ability to apply concepts such as fractions, percentages, ratios, and proportions.
• Reasoning Ability:
  Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to perform statistical analysis.
• Computer
  
  Skills:
  
  Familiar with Microsoft Word, Excel, Outlook or similar e‑mail program. Also familiar with using a statistical program such as Mini Tab.
• Certificates and Licenses:
  No certifications required. ASQ certification preferred.
• Supervisory Responsibilities:
  
  This position has no supervisory requirements.
• Attendance and Punctuality:
  Consistently at work and on time; ensures work responsibilities are covered when absent, arrives at meetings and appointments on time and prepared.
• Dependability:
  Follows instructions; responds to management direction; takes responsibility for own actions; keeps commitments; completes tasks on time or notifies appropriate management.
• Problem Solving:
  Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem‑solving situations; uses reason even when dealing with emotional topics.
• Interpersonal:
  Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to other’s ideas and tries new things.
• Oral Communication:
  Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; participates in meetings.
• Written Communication:
  Writes clearly and informatively; edits…