Senior Validation Engineer

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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

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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay 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/vision insurance and 401(k) to eligible employees.​​

• This job is eligible to participate in our short-term incentive programs. ​​

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Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 AbbVie’s 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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