Senior Validation Engineer
Senior Validation Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 multidisciplinary 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 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 CleanInPlace and SteamInPlace theory and techniques is required
Experience with riskbased 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 handson 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 multitask 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 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 shortterm incentive programs.
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 Companys sole and absolute discretion unless and until paid and may 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
