Aseptic Process Engineer/Lead

Company Description


QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Job Description


Aseptic Process Engineer/Lead to design and support the aseptic manufacturing processes at designated locations.
Responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation investigations and change management. Able to work cross-functionally with Quality, Operation, Maintenance, Validation, and Sterility Assurance to deliver key milestones for projects.

Responsibilities:

* Responsible for technical support of formulation, aseptic filling and sealing operations.
* Leads and supports Aseptic process simulations.
* Conducts and writes formal investigation reports with the assistance of plant personnel.
* Performs impact risk assessment as well as assisting in root cause determination and plans appropriate corrective action and preventative action.
* Performs reviews and evaluates sensitive, confidential information and develops recommendations for use by Manufacturing operations.
* Utilize change management systems to author and update documents and procedures.
* Liaise with site departments such as Manufacturing, Analytical and Quality as required to meet project deadlines and cGMP requirements.
* Perform necessary assessments of aseptic operation and update necessary documents.
* Assist in managing investigation workload for the department to ensure investigations/ CAPAs are completed within the assigned time frame.
* Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing and the use of single-use container systems.


Qualifications

* Bachelors Degree in a technical field required.
* Minimum of 5 years experience in aseptic pharmaceutical manufacturing and/or quality environment required.
* Requires thorough knowledge of GMPs and understanding in aseptic processing.
* Bilingual (Spanish/English).
* Must have the ability to handle multiple projects in a dynamic environment.
* Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
* Working knowledge of 21CFR part 211 FDA regulations.
* Knowledge of various quality and root cause analysis tools.
* Prior investigation writing experience (with determination of product impact).
* MS Office (strong knowledge).


Additional Information


All your information will be kept confidential according to EEO guidelines.