Senior Engineer, Validation Commissioning (onsite role in MA)
- 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.
- Able to support broader aspects of projects at times including: 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.
- Leads Execution of Risk Managementincluding, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, 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. Demonstrated success in FMEA authorization/facilitation.
- Qualification as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
- Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
- Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
- 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
- Ability to supervise junior or contract team members (prior supervisory experience preferred)
- Ability to manage complex projects and multiple projects (5+) simultaneously
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
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