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Job Description

One of our large Pharmaceutical clients is seeking a Quality Engineer Validation Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight and validation support for manufacturing activities related to commercial operations for production of cell therapy products. You will also be maintaining quality systems and oversight to ensure the validation/qualification and operation of processes and procedures for this external site. This will involve reviewing current systems, recommending and executing on improvements, and implementing GMP tracking tools to assure no future gaps. We are seeking someone who can help to build/assess current state of Validation/Metrology/Maintenance program/systems.

Other responsibilities include:

-Acting as sponsor's representative and main point of contact for manufacturing decisions

-Providing oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, qualification protocols, validation plans, and validation summary report

-Developing and executing protocols and analyzing results for a variety of qualification and validation functions

-Resolving manufacturing issues and conducting deviation investigations, root cause analysis and the identification and implementation of CAPAs

-Authoring, reviewing, executing and approving technical documents updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation

-Driving continuous improvement and process optimization efforts on quality standards, requirements, and overall best practices

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

-Bachelors Degree in a Science or Engineering related field of study

-Minimum 5 years of experience in pharmaceutical GMP environments

-Minimum 8 years of related quality engineering or validation manufacturing support experience

-Strong expertise in defining gaps and remediation for validation, calibration, and PM systems.

-Strong QMS and IQ/OQ/ PQ skills null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.