Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
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.
Primary Responsibilities:
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
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
Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols
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
Qualifications
Qualifications
Education:
BS Degree in engineering or technical discipline with a minimum of minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.
Background:
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 preferred
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 preferred
Experience with continuous improvement to streamline practices & procedures is preferred
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
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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