Validation Engineer

Validation Engineer           

Job Summary:   The Validation Engineer is a member of the Engineering Department and reports directly to the Engineering Manager. This position requires strong written (technical) and verbal communication skills that facilitate close collaboration between production, sales, marketing, finance, quality assurance and control. This position is responsible for identification and qualification of new manufacturing equipment and processes. This position requires a strong understanding of how the product is manufactured, packaged and sterilized and plays a key role in maintaining the validation program (Master Validation Plan). An initial emphasis on packaging will be required for this position focused primarily on sterile barrier systems. A transition to production processes and equipment is to follow.

Essential Functions:

• Protocol/Report development and execution
• Statistical Techniques
• Data analysis
• Verification and Validation Activities
• Engineering studies
• Procedure development
• Work with marketing on developing new packaging methods and systems
• Troubleshoot packaging design problems and challenges
• Provide technical support as necessary for new product development
• Actively participant in design review
• Provides technical support to manufacturing and packaging operations.
• Provides analytical review of change recommendations, initiation of ECO’s, and coordinates document changes
• Coordinate all physical process validation activities
• Interact with Production Supervisors and provide training per written protocols, design and validation testing
• Coordinate with the Quality for test method design and validation testing
• Coordinate upcoming manufacturing transfer activities which includes all transfer and process validation activities as well as layout plans for the physical work flow

Education and Experience:

• Bachelor’s degree in Engineering
• Minimum of 3 years manufacturing experience.
• Medical device manufacturing industry experience a plus

Knowledge, Skills and Abilities: 

• Knowledge of Statistical Process Control (SPC) required
• Strong understanding of sterile barrier packaging concepts and a working knowledge of FFS and bar sealing equipment
• ISO 13485, GMP and Quality Systems Regulations
• ISO 11607
• Must read and speak English
• Project management and presentation skills

• Strong Documentation bias – documenting all validation activities and following internal and external SOPs.
• Attention to detail – it is critical that every test result and measurement be assessed for accuracy and identify when something is not right.
• Analytical thinking – assess data and identify where issues arise and provide solutions.
• Team player, self-driven, enthusiastic – validation requires input from multiple parties. Teamwork is vital to this position’s success.
• Flexible, ability to work independently.

• Ability to work under pressure.
• Ability to travel as needed. 
• Strong Microsoft Office skills.
• Excellent interpersonal skills.
• Data Driven, results oriented.

Physical Capabilities:

Lifting of items up to 25 pounds on occasion may be required.