What are the responsibilities and job description for the Quality Engineer position at Orbis Clinical?
Job Title : Contract Lead Engineer, Quality Validation
Location : Andover, MA (Hybrid)
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 technology transfers, including development and engineering activities to be leveraged
- Provide quality oversight for drug product process qualification / validation protocol, exception, and report reviews
- 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 :
EEO and Reasonable Accommodation Statement :
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
