What are the responsibilities and job description for the Contract Lead Engineer, Quality Validation position at United Consulting Hub?
Job Title : Contract Lead Engineer, Quality Validation
Location : Andover, MA
Contract : 12 months
Job Description Summary
The Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to process validation for both internal customers and CMOs / CTLs. The individual will support and facilitate the development of project plans, qualification protocols and reports for all stages of the qualification process.
Primary Responsibilities include :
- Provide quality oversight for drug product process qualification / validation protocol, exception, and report reviews
- Provide quality oversight for drug product process technology transfers, including development and engineering activities to be leveraged
- Provide quality validation oversight at contract manufacturing organizations (CMOs), including continued process verification (CPV), product quality reviews (PQR), supporting investigations and deviations as needed
- Adhere to regulatory guidance, policies, and procedures for technology transfer and process validation
- Independently coordinate and directly interface with multiple departments both internally and with our contract manufacturing and testing organizations
- Use risk management principles for qualification and remediation efforts
- Provide regular updates directly to Management
- Perform other related duties as assigned
Education and Skills Requirements :
