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Associate Validation Engineer

Company: AbbVie
Location: Worcester
Posted on: August 4, 2022

Job Description:

AbbVie Bioresearch Center in Worcester, MA is seeking an Associate Engineer to join the Quality Validation Group for the validation of biologics equipment.
The selected candidate will be responsible for commissioning and qualification activities associated with lifecycle validation projects involving engineering changes to existing equipment and processes, introduction of new manufacturing processes, support of existing manufacturing processes, and continuous improvement of validation processes to enable more agile change control. The engineer will work in a multi-disciplinary team environment.
Primary Responsibilities:
Prepare validation test protocols, perform/coordinate validation testing in concert with all stakeholders, and analyze/assemble test results and complete documentation necessary to create finished validation summary reports as required
Assist in the review of completed test documentation to ensure compliance with test procedures and cGMPs
Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management
Provide input on risk assessments and system classifications
Review new equipment specifications
Manage continuous improvement projects and drive to completion
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
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.
Entry level position, less than two years of experience is typical.
An understanding of basic unit operations involving cell culture and protein purification is desired
Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is desired
Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is desired
Experience with risk-based approach to commissioning and qualification preferred
Experience with temperature mapping of environmental chambers, autoclave validation is desired
Familiarity with distributed control systems and process logic controllers is desired
Familiarity with P&IDs, loop diagrams, etc. is desired
Hands-on experience with the Kaye Validator is desired
Familiarity with project management is desired
Experience with continuous improvement to streamline practices & procedures is desired
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 demonstrate strong interpersonal & teamwork skills
Significant Work Activities and Conditions:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous standing/walking for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Work in a manufacturing environment with: awkward/forceful/repetitive(arms above shoulder, bent wrists) use of arms
Work in a clean room environment
Lift, carry, push or pull weights of more than 20 pounds on a regular basis
Routine work with chemicals
Wear ear plugs
Work at heights, e.g. ladders, scaffolds, catwalks, etc.
Work requiring repeated bending, stooping, squatting or kneeling

Keywords: AbbVie, Worcester , Associate Validation Engineer, Engineering , Worcester, Massachusetts

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