Validation Engineer

The Validation Engineer will assume the role of validation technical expert on specific project teams. He or She will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as the key validation representative in support of project team activities and process design to ensure cGMP compliance and interdepartmental consistency to the site validation master plan and strategy. The incumbent will actively collaborate with multiple functions as an individual contributor and within project / product teams to:
• Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ, PV and/or CV) for aseptic pharmaceutical manufacturing
• Prepare equipment, processes, product, and cleaning procedures
• Derive and document validation plans and protocols (tests) to provide objective evidence that equipment, processes, and product meet requirements and are compliant with applicable regulations
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
• Assign individuals in conjunction with area management to develop and implement validation test plans
• Oversee validation testing for new products and process improvements
• Interact with individuals from different disciplines (Engineering, Science, and Business) to plan, execute, and complete validation activities
• Ensure validation efforts are conducted in an appropriate and timely manner
• Perform and lead risk assessment exercises in support of validation activities
• Prepare Technical Packages and assessments for product transfers
• Act as back up to Validation peers as needed
• Other duties as assigned by area management

Qualifications:

Required Skills and Knowledge - Bachelor's degree in related field; science, engineering, or manufacturing technology. Minimum 5 years pharmaceutical manufacturing experience. Experience with high performance teams and development of regulatory staffs is desirable. Leadership, having provided leadership to exempt and non-exempt employees. Strong interpersonal and project management skills; must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately. Demonstrated business acumen with a proven track record of best practice implementation and accomplishments involving quality, manufacturing, engineering, and warehousing. Ability to work both independently and in partnership with others, proven ability to use initiative and drive to achieve results. Strong conflict resolution skills. Expertise in Microsoft Office applications, including Word and Excel, and data entry experience a plus. Must be willing to travel both domestically and internationally. Must be able to work multiple shifts as needed to meet deadlines.

Technical Area of Expertise - Recognized expertise in regulatory requirements, validation practice, pharmaceutical manufacturing to include aseptic processing, packaging, and labeling technologies.

Please reference code 4026MH on all resumes and cover letters.

Location:

Compensation:
DOE

Contact:
Mindy Hanger
Recruiting Manager
Email: mindy@insearchrecruiting.com
Phone: 402.964.1200
Fax: 402.964.1212