Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Senior Quality Engineer Quality Assurance Engineering. will provide Quality oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Senior Quality Engineer will be responsible for supporting the design installation and evaluation of equipment utilities components products and computer systems while ensuring they are fully operational effective and free from defects during the entire system lifecycle. Further support the formulation of quality policies procedures as well as conducting training on quality concepts/ addition the Senior Quality Engineer will support audit and submission activities for regulatory compliance.
Essential Functions and Responsibilities
- Identifying risk developing complex mitigation strategies alternative solutions resolving issues etc. in collaboration with cross functional groups such as Manufacturing Quality Control IT Engineering and Validation.
- Supporting the oversight of Data Integrity and Computer System Validation efforts system lifecycle and improvements for laboratory and manufacturing systems enterprise applications and infrastructure.
- Supporting cGMP quality improvement efforts at iCTC (Philadelphia PA) and in remote facilities such as IOVAA (Philadelphia PA).
- Providing Quality oversight of system change management requirements configurations detailed designs technical specifications and test scripts.
- Creating and maintaining company documentation such as quality manuals and quality procedures.
- Applying good manufacturing practice and observing that it is being adhered to.
- Represent Quality on crossfunctional teams to complete projects address quality issues and implement quality system improvements.
- Provide technical guidance to crossfunctional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations addressing purchased component quality issues complaint product evaluations development and implementation of corrective actions initiation and approval of product/process changes and disposition of discrepant material.
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
- Perform miscellaneous duties as assigned.
Required Education Skills and Knowledge
- BA/BS degree in scientific or engineering discipline.
- A minimum of 8 years of biopharmaceutical industry experience in a technical or supporting technical role with Bachelors degree; or 6 years and a Masters degree.
- A minimum of 5 years leading or supporting GxP Computer System implementation and validation.
- Demonstrable experience creating and utilizing manufacturing and laboratory testing systems.
- Ability to comprehend technical design and specification documents for software systems and applications.
- Strong experience developing and executing protocols for singleuse process systems lab systems and software applications in a cGMP environment
- Demonstrable experience creating and maintaining policies processes and procedures for a new cGMP facility
- Demonstrable experience utilizing riskbased assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
- Ability to effectively communicate with management and project team members.
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
- Strong professional interpersonal and communications skills both verbal and written to provide clear direction for the business vendors internal stakeholders.
- Ability to meet deadlines and multitask efficiently.
- Must be comfortable in a fastpaced environment with minimal direction and changing priorities.
- Experience identifying changes driving improvements and streamlining processes required.
- Proficient with the Microsoft Office Suite Word Excel PowerPoint and Project.
Preferred Education Skills and Knowledge
- A minimum of 2 years experience in a Quality role is highly desirable.
- Experience in preparing for and participating in regulatory inspections to ensure successful outcomes.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office andexert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures viewing a computer screen and extensive reading.
- This position requires repetitive motion substantial movements (motions) of the wrist hands and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex bleach loud noise lab equipment hazards strong odors and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Full-Time
