Packaging Validation Engineer

Title: Packaging Validation Engineer

Location: Ohio (Open to local residents only)

Work Arrangement: Onsite

Contract Duration: 1 year contract

Number of Positions: 10

SUMMARY

Our client is seeking experienced Packaging Validation Engineers to support packaging process characterization and validation activities within a regulated pharmaceutical or biologics manufacturing environment.

The ideal candidates will have extensive experience in Packaging Process Characterization and Process Validation, with a strong understanding of the complete validation lifecycle, from planning and protocol development through execution, data analysis, documentation, and final reporting.

Candidates must have hands-on experience supporting pharmaceutical or biologics manufacturing operations, with the technical ability to evaluate packaging processes, assess process performance, troubleshoot issues, and ensure that packaging operations consistently meet established quality standards and regulatory requirements.

KEY RESPONSIBILITIES

• Support packaging process characterization and process validation activities within a regulated manufacturing environment.
• Develop, review, and execute packaging validation protocols and supporting documentation.
• Support the complete validation lifecycle, including planning, protocol development, execution, data analysis, documentation, and final reporting.
• Evaluate packaging process performance, identify process variations, and support the implementation of appropriate improvements.
• Perform technical assessments and support troubleshooting of packaging process-related issues.
• Review and analyze validation data to verify compliance with established acceptance criteria.
• Support qualification and validation activities for packaging equipment and manufacturing processes.
• Collaborate with Manufacturing, Engineering, Quality Assurance, and other cross-functional teams to ensure successful execution of validation activities.
• Ensure validation documentation and activities comply with applicable GMP requirements, internal procedures, and regulatory standards.

REQUIRED QUALIFICATIONS

• Demonstrated experience in pharmaceutical or biologics manufacturing environments.
• Extensive hands-on experience with Packaging Process Characterization and Packaging Process Validation.
• Strong knowledge of the complete validation lifecycle.
• Experience developing and executing validation protocols and preparing technical documentation.
• Understanding of GMP requirements and regulated manufacturing operations.
• Strong analytical, troubleshooting, and problem-solving skills.
• Ability to work onsite and collaborate effectively with cross-functional teams.

PREFERRED QUALIFICATIONS

• Experience supporting packaging validation projects in pharmaceutical or biologics manufacturing facilities.
• Experience with process characterization studies, validation data analysis, and technical reporting.
• Experience with packaging equipment qualification and process performance assessments.
• Familiarity with validation documentation, quality systems, and continuous improvement initiatives.

EDUCATION

Bachelor's degree in Engineering, Chemistry, Biology, or a related scientific or technical discipline is preferred.

ADDITIONAL REQUIREMENTS

• Must be a local resident of Ohio.
• Must be available to work onsite.
• Must be available for the full 1 year contract assignment.