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AbbVie Bioresearch Center in Worcester, MA is seeking a Sr. Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.
The selected candidate will be expected to take a leadership role in the Group managing daily activities of qualification/validation projects and continuous improvement projects. Projects will involve engineering changes to existing equipment and processes, introduction of new manufacturing processes, support of existing manufacturing processes, continuous improvement of engineering processes and support of other Groups within the Engineering department to enable more agile change control. The engineer will work in a multi-disciplinary team environment.
- Consult as a member of a Team of Qualification/Validation Subject Matter Experts on matters concerning facility, utility and equipment (FUE) validation, automated process control (APC) validation, sanitary practices including clean-in-place (CIP) and steam-in-place (SIP), cleaning validation, shipping validation, autoclaves and environmental chambers
- Design validation test protocols, perform/coordinate validation testing in concert with all stakeholders, and analyze/assemble test results to create a finished validation test protocol as required
- Perform validation tests, prepare test protocols, and complete documentation necessary to support production activities
- Review and approve documentation as assigned
- Review new equipment specifications
- Manage continuous improvement projects and drive to completion
- Mentor and guide junior engineers and engineering technicians in the development and execution of equipment change control plans and qualification/validation test protocols
- Assist in the review of completed test documentation as a member of Site Validation Review Board to ensure compliance with test procedures and cGMPs
- Work with appropriate departments and personnel to resolve validation testing issues
- Advise other departments on SOPs related to validation projects
- Maintain 100% on time training
- Execute assigned jobs and tasks according to schedule prepared by Engineering Planning
- Achieve Site, Department and Group performance metrics
- Complete other special projects and assignments as required
- Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
BS Degree in engineering or technical discipline with a 6 - 8 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
- Expertise in Clean-In-Place and Steam-In-Place theory and techniques is required
- Experience with cleaning validation is preferred
- Experience with shipping validation is desired
- Experience with temperature mapping of environmental chambers, autoclave validation and qualification of freezing procedures is strongly desired
- Familiarity with distributed control systems and process logic controllers is required
- Adherence to cGMP and GDP is required
- Strong technical writing skill is required
- Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred
- Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously
- Must have familiarity with P&IDs, loop diagrams, etc.
- Must be able to write and execute validation plans, protocols and reports for process equipment changes per existing procedures and templates, and will be required to create validation plans and protocols for non-routine equipment or test needs
- Experience with continuous improvement to streamline practices & procedures is preferred
- Must define, coordinate and execute technical tasks independently on moderately sized projects and support peers by executing tasks on larger, more complex projects
- Must demonstrate strong interpersonal & teamwork skills
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.