BioPharma Consulting JAD Group
Boston, MA
Job Details
Contract
Full Job Description
We are continuously seeking skilled professionals to join our Facilities and Operations team, particularly within Reliability Engineering. This posting represents an evergreen opportunity to build a pipeline of talented CQV Engineers for current and future projects.
Key Responsibilities:
- Develop and revise qualification documents for process equipment, analytical instruments, facilities, and utility systems.
- Perform in-field execution of commissioning and qualification protocols.
- Compile complete qualification packages, including executed protocols, summary reports, and requirements traceability matrices (RTMs).
- Conduct data analysis to support recommendations included in summary reports, as needed.
- Author and execute protocols and reports for requalification activities of utility and manufacturing systems.
- Manage and resolve deviations and non-conformances related to CQV deliverables.
- Lead and drive CQV activities for assigned systems, ensuring timely completion aligned with project schedules.
- Collaborate with client stakeholders while maintaining autonomy in managing and closing CQV deliverables.
Requirements
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
- Experience in commissioning, qualification, and validation (CQV) within GMP-regulated environments.
- Strong technical writing and documentation skills.
- Ability to work independently with minimal supervision.
- Effective communication and collaboration with cross-functional teams.
Benefits
- Contract