Quality Engineer

Location
Gaithersburg, MD, US
Posted
Sep 01, 2020
Ref
672007000
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
  1. JOB SUMMARY

The Quality Engineer provides functional and strategic support to in-house and CMO teams to ensure consistent implementation of quality concepts especially those associated with drug developmental programs and ensures the successful and timely release of GMP process development products/supplies and GMP clinical supplies by providing quality direction on manufacturing options, capabilities, and providing quality oversight of the overall manufacturing and testing process.
  1. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Maintain relationships with vendors, contractors, and consultants to ensure effective execution of assigned drag development tasks per phase appropriate guide.
  • Liaise with suppliers in addressing nonconformities through thorough investigations. Assess and determine appropriateness of corrective/preventive actions to avoid recurrence
  • Contribute to risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Product User Risk Analysis, Risk Benefit Analysis and Risk Management Report
  • Promote a GxP and Quality mindset at all levels within the aspects of a development organization
  • Partner with the project teams charged with the delivery of the pipeline projects ensuring that combination product (drug and device) and broader quality considerations are an intrinsic part of project delivery
  • Act as a company authority for the interpretation of GxP regulations and guidance documents
  • Support both process and equipment IQ/OQ/PQ validation activities.
  • Support Internal/external Audit. Able to record Audit observations and prepare and/or review written QA reports for audits and inspections.
  • Develop and maintain tracking reports, scorecards, and other tools to monitor quality
  • Manage and oversee responses and CAPAs in response to audits.
  • Assists in the investigation and writing of non-conformances such as deviations, complaints, OOS, OOT, deviations, etc.
  • Perform statistical analysis using statistical software like Minitab
  • Responsible for identifying defects and have the authority to report device defects at any time


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • Minimum of 3-5 years of Quality Engineering, product development and/or process engineering experience
  • BS degree preferred in Science or engineering
  • 1-3 years minimal of GMP experience working within ISO 13485 and/or FDA 21CFR Part 820 and FDA 21 CFR Part 210 and 211 environments
  • 1-2 years of equipment and process validation (IQ/OQ/PQ) experience
  • Knowledge of ICH guidelines preferred
  • Ability to interpret equipment specifications (ex: URS, CAD Drawings) and Piping/Instrumentation Diagrams (PID) preferred
  • Experience in working in a project team environment
  • Be able to handle multiple projects


  1. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.