We are looking for an experienced Validation/Characterization Engineer with a strong background in pharmaceutical manufacturing equipment. The ideal candidate will have at least 5 years of hands-on experience with thermoformers, labelers, and cartoners. This role involves leading validation and characterization activities to ensure that all equipment and processes meet regulatory requirements and industry standards.

Key Responsibilities:

• Lead the validation and characterization of thermoformers, labelers, and cartoners used in pharmaceutical manufacturing.
• Develop and execute validation protocols (IQ, OQ, PQ) and characterization plans.
• Analyze and document data to ensure equipment and processes meet predefined specifications.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure seamless project execution.
• Troubleshoot and resolve issues related to equipment performance and process deviations.
• Ensure compliance with FDA, GMP, and other regulatory standards.
• Prepare detailed reports and documentation for validation and characterization activities.
• Provide training and support to junior engineers and technical staff.

Qualifications:

• Bachelor’s degree in Engineering, preferably Mechanical, Electrical, or Chemical Engineering.
• Minimum of 5 years of experience in validation and characterization within the pharmaceutical or medical device industry.
• Extensive experience with thermoformers, labelers, and cartoners is required.
• Strong understanding of FDA, GMP, and other relevant regulatory guidelines.
• Excellent analytical, problem-solving, and technical writing skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Strong communication and interpersonal skills.

Preferred Qualifications:

• Master’s degree in Engineering or related field.
• Certification in Lean Six Sigma or similar methodologies.
• Experience with automated systems and process validation in a regulated environment.