Job Description
An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.
Responsibilities
- Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
- Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
- Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications.
- Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
- May support aspects of projects at times such as: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
- Supports Execution of Risk Mngmnt. including, periodic review and update per the Validation Master Plan, interface with best practices, , ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. May perform FMEA authorization/facilitation.
- May have Qualification as QRM facilitator commensurate with responsibility.
- Works with contract validation resources as part of a team in the timely completion of activities in his/her area of responsibility
Qualifications
- Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 1+ years of significant engineering and/or operational experience
- Experience in the development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred.
- Familiarity with Python coding, qualifying automated process controls system desired.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
- Works with junior or contract team members as part of a team
- Ability to manage multiple projects (3+) simultaneously
