Associate CQV Engineer - Katalyst Healthcares & Life Sciences
Norton, MA 02766
About the Job
Responsibilities:
- Support protocol/report generation and on the floor test execution, for various opex and capex projects, and anything else related to cleaning and facilities, equipment, and utility (FEU) validation and requalification activities.
- Complete temperature mapping.
- Experience in facilities, equipment, and utility and cleaning validation is preferred
- Provide technical CQV (commissioning, qualification, and verification) support on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently.
- Support the development and execution of technical commissioning and qualification documentation for complex, automated equipment and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
- Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
- Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
- Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.
- Requirements
- Bachelor's degree in an engineering or scientific degree, or equivalent.
- 1 - 3 years' experience in a GMP regulated environment.
- Experience with temperature mapping, protocol authoring and execution, and writing protocol deviations preferred.
- Proficient with Microsoft Office Suite.
- Proven attention to detail and organization in project work.
- Excellent verbal and written communication skills.
- Motivation to learn and succeed in a fast-paced environment
Source : Katalyst Healthcares & Life Sciences