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12625
PERM

Process (Validation) Engineer

Location: Leominster,

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Process Validation Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Permanent
  • Pay rate:  Open – Market Rate
  • Job Location:  Leominster, MA
  • Job#: bh12625

 

Process Validation Engineer

The Process/Validation Engineer will oversee, evaluate, and calibrate equipment, systems, and procedures used in the development and production of products and will ensure safety, quality, and purity requirements are met.


KEY ACCOUNTABILITIES:
• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards
• Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
• Identifies root causes of production problems
• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations
• Develops and maintains databases for tracking test results, validation activities, or validated systems
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices
• Modifies testing methods or revisits test objectives and standards to resolve testing problems
• Calibrates equipment to ensure accurate measurements
• Performs other related duties as assigned
• Must know all aspect of the injection molding process
• Must fill out process data logs and monitor the setting to make sure they stay in the validated state
• Thorough understanding of related equipment and the ability to perform equipment modifications
• Thorough understanding of industry standards and regulatory guidelines

• Thorough understanding of applicable mathematics and scientific practices
• Must be able to create floor layouts to make jobs streamline and be more efficient for our operators.


JOB QUALIFICATIONS:
• Bachelor’s degree in related field required.
• At least one year of related experience preferred.
• Excellent verbal and written communication skills
• Excellent interpersonal skills
• Proficient with Microsoft Office Suite or related software
• Scientific mold experience, a must
• Priamus or RJG experience a plus
• Can perform DOE as part of process development
• Lean manufacturing, a plus
Must be able to excuse IQ-OQ-PQ Protocols
• Knowledge of Minitab a plus

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

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