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Job Description
Purpose
AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.
The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.
Responsibilities:
1. Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required
2. Execute assigned projects, jobs, and tasks according to schedule prepared by Engineering Project Management
3. Provide input on risk assessments and system classifications
4. Review new equipment specifications
5. Manage continuous improvement projects and drive to completion
6. Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols
7. Work with appropriate departments and personnel to resolve validation testing issues
8. Advise other departments on SOPs related to validation projects
9. Maintain 100% on-time training
10. Achieve Site, Department, and Group performance metrics
11. Complete other special projects and assignments as required
12. Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs
Qualifications
Key Stakeholders
Engineering Management, Operations Management, EH&S Management, R&D Management
Additional Information
* BS Degree in engineering or technical discipline with a minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.
* An understanding of basic unit operations involving cell culture and protein purification is required
* Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation, and controls is required
* Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is required
* Experience with risk-based approach to commissioning and qualification
* Experience with temperature mapping of environmental chambers, autoclave validation is desired
* Familiarity with distributed control systems and process logic controllers is required
* Must have familiarity with P&IDs, loop diagrams, etc.
* Must have hands-on experience on the Kaye Validator
* Familiarity with project management is desirable
* Experience with continuous improvement to streamline practices & procedures is desirable
* Adherence to cGMP and GDP is required
* Strong technical writing skills are required
* Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are required
* Ability to work independently with adequate supervision, multi-task, and support several projects simultaneously
* Strong interpersonal and teamwork skills
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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